Symptoms and General Pathology

All Conditions

Infections

Shock

Shock, Septic

Sepsis

Toxemia

Communicable Diseases

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

Natriuretic Agents

Vasoconstrictor Agents

Coagulants

All Drugs and Chemicals

Amino Acids

Vasopressins

Arginine Vasopressin

Norepinephrine

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Sympathomimetics

Hemostatics

Arginine

Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement

Vasopressin

Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement

Cristiane M Zambolim, MD

Although arginine vasopressin has been used as an additional drug in refractory shock in worldwide clinical practice, there are no prospective studies using it as a first choice therapy in patients with cancer and septic shock.

The aim of this study is assess if the use of arginine vasopressin would be more effective on treatment of septic shock in cancer patients than norepinephrine, decreasing the composite end point of mortality and organ failure in 28 days.

Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients

Mortality from all causes in 28-day follow-up

Mortality from all causes 90 days after randomization

Days alive and free of mechanical ventilation at 28-day follow-up

Days alive and free of any type of vasopressor agent at 28-day follow-up

requirement of dialysis of hemofiltration at 28-day follow-up

Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 24 hours after randomization.

Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 96 hours after randomization.

Instituto do Cancer do Estado de São Paulo

Principal Investigator

Neoplasms

Skin and Connective Tissue Diseases

Leiomyoma

Hemorrhage

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Agents

Reproductive Control Agents

Misoprostol

Antacids

Anti-Ulcer Agents

Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy.

Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement .

20 units diluted in 100mL of Normal Saline injected laparoscopic needle

Standard

20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg

Standard-vaginal misoprostol

Pedram Bral, M.D.

Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.

Uterine fibroids are common benign tumors affecting women, and produce symptoms severe enough to warrant treatment in 20-50% of reproductive age women, including abnormal uterine bleeding, pelvic pain, and infertility. While hysterectomy with removal of the uterus is standard of care for symptomatic uterine fibroids, women desiring future child bearing require removal of the fibroids alone via uterine myomectomy, with re-construction of the uterus after removal. A well established risk to such a procedure is the operative blood loss, which can be quite significant due to the increased blood supply fibroids accumulate. Several interventions have been looked at as potential methods to help decrease operative blood loss. Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. A known potential side effect of vasopressin is cardiovascular compromise, which can be catastrophic if vasopressin is inadvertently injected into the large vessels of the uterus. This limits the amount that can be safely used in surgery. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus. While Vasopressin is more commonly used during surgery, the associated potential risks limit the amount that can be safely administered. However, the addition Misoprostol, with a relatively safe side effect profile, can further improve control of the blood supply and decrease operative blood loss. Misoprostol can be administered orally, sublingually, or as vaginal or rectal suppositories. While the systemic absorption of vaginal Misoprostol is slower in onset than the oral or sublingual routes, the effect is maintained for a longer period of time, and is more conducive to use during laparoscopic or robotic assisted myomectomies given the prolonged operative time associated with minimally invasive techniques when compared to traditional open approaches. This study aims to determine whether using vaginal Misoprostol in combination with Vasopressin is more effective at decreasing operative blood loss during robotic assisted laparoscopic myomectomy than Vasopressin alone.

Combined Vaginal Misoprostol and Perivascular Vasopressin

A Randomized Control Trial of Combined Vaginal Misoprostol and Perivascular Vasopressin During Robotic Myomectomy

The difference in hemoglobin levels between pre surgery and post surgery

Antonios Likourezos

Research Administration Director

Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy.

Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg

Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement .

Standard: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle

Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg

Standard-Vaginal Misoprostol

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Pedram Bral, MD

Hemoglobin Levels Difference Between Pre and Post Surgery.

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

removal of ovarian vessels

John H Farley, MD

This study will evaluate the expression of arginine vasopressin (AVP) by peptide and mRNA quantitation and also measurement of its V1 receptor mRNA, in the arteries and veins of ovarian malignant (cancerous) or benign (non-cancerous) tissue. The investigators will examine whether AVP protein and AVP and V1 receptor mRNA expression vary with respect to tumor histology, intratumoral vascularization and systemic blood pressure.

d. STATUS: Background and Significance/Preliminary Studies

Neovascularization is an obligate early event in cancer growth. Consequently, angiogenesis appears to play an important role in disease progression and survival of most malignancies in general and gynecologic malignancies specifically. Ovarian cancer is the second most common gynecologic malignancy, and the leading cause of cancer related death among the gynecologic malignancies. It is estimated that 23,300 new cases of ovarian cancer will be diagnosed in the United States in 2003 and that 13,900 women will die from disease. Angiogenesis may serve as a prognostic indicator in ovarian cancer. Angiogenesis in cancer requires the proliferation and migration of endothelial cells in response to a variety of cytokines to include angiogenin, endothelial cell growth factor, and vascular endothelial growth factor (VEGF). The expression of some of these cytokines have been evaluated in gynecologic malignancies. Increased expression of VEGF protein by immunohistochemistry has been associated with decreased disease free survival 18 versus 120 months in early stage epithelial ovarian cancers. Conversely any exposure to antiangiogenic factors should inhibit tumor cell growth in vitro. Angiostatin and endostatin have also been found to inhibit ovarian cancer growth in mice 7.

The neovascularization required of fast growing malignancies in general, and ovarian cancer specifically, necessitates that they contain many new vessels that have less smooth muscle in their walls. Because of the quantitative decrease in vascular smooth muscle these vessels also have a decreased resistance to blood flow than the vessels found in benign tumors. Malignant tumors with low vascular resistance have been shown to demonstrate decreased smooth muscle actin expression and intense Cd34 expression with no differences in microvessel density (MVD) noted 8. Immunohistochemical analysis using monoclonal antibodies against smooth muscle actin (SMA) and CD34 (an endothelial cell marker) demonstrated that low resistance to blood flow in vessels within malignant ovarian tumors may be associated with a poorly developed muscular coat in the tumor vessels, compared with that observed in benign tumors. Color-flow Doppler imaging uses the altered blood flow patterns as a marker in an attempt to differentiate benign from malignant tumors 9. Researchers have evaluated the presence of intratumoral vascularization in ovarian neoplasms by Color-flow Doppler ultrasound. Benign tumors and cysts have a significantly higher pulsatility index (PI) (mean, 1.93 +/- 1.02; range, 0.23-3.99) and resistive index (RI) (mean, 0.77 +/- 0.22; range, 0.2-1.0) than do malignant tumors (PI: mean, 0.77 +/- 0.33; range, 0.31-1.09; RI: mean, 0.5 +/- 0.17; range, 0.27-0.67). Some overlap, however, exists in individual values for benign and malignant lesions. The difference in the angiogenic and vascular resistant natures of benign and malignant ovarian tumors showing intratumoral blood flow may thus be correlated with the endothelial cell activity of the tumor vessels and not the MVD. This low resistance to blood flow within tumor vessels and subsequent endothelial cell activity could be regulated by local, endothelial cell or vascular smooth muscle cell, arginine-vasopressin (AVP) synthesis and release with subsequent actions on vasopressin receptors.

Arginine-vasopressin (AVP) is a peptide hormone classically known to be synthesized in the hypothalamus and secreted by the posterior pituitary gland. AVP has a variety of roles in the body and a variety of systemic physiologic functions to include vasoconstriction, gluconeogenesis, corticosteroidogenesis, and excretion of water and urea. AVP causes a peripheral vasoconstriction that is thought to be mediated primarily by the V1 receptor. AVP is thought to do this by a variety of mechanisms to include activation of the V1a receptors with stimulation of phospholipase A2 which leads to increased calcium spiking activity. AVP could also do this by regulating the expression of other hypertensive factors and proteins in the body. AVP has been shown to play an important role in the development of hypertension following aortic constriction in rats. When rats were given AVP following constriction of the abdominal aorta, hypertension developed and these animals had an increased response to angiotensin II. Therefore AVP is thought to permit the expression of other factors such as angiotensin II. The presence of AVP is important in other animal models of hypertension such the spontaneously hypertensive rat and DOCA salt hypertension. For instance, administration of DOCA salt to Brattleboro rats, genetically incapable of synthesizing vasopressin in the hypothalamus, will not result in the development of hypertension. However, with administration of exogenous AVP, these rats will develop hypertension when given DOCA salt treatment.

Exposure of vascular smooth muscle cells to AVP also increases smooth muscle actin through activation of all three MAP kinase family pathways. Because AVP has the ability to regulate and increase smooth muscle actin this suggests that AVP may not only regulate growth of vascular smooth muscle but also promote expression of smooth muscle-specific contractile proteins . Previous studies have shown that AVP can produce an exaggerated vascular vasoconstriction in young spontaneously hypertensive rats (SHR) relative to normotensive rats. This exaggerated response was likely associated to a higher density of V1 receptors associated with increased AVP gene expression. Finally AVP and other neuropepetides have been shown to serve as autocrine growth factors for some solid tumors. The mitogenic influence of AVP is thought to involve increases in intracellular calcium. AVP is often expressed in small cell lung cancer (SCLC), and can act as an autocrine growth factor in these cancers. AVP expression in SCLC is thought to be dependent on the modulation of normal repressor activity 12. Because AVP has been implicated in the physiology of vascular constriction and mean vascular pressure, and also because it has been shown to be expressed in certain types of cancer, it may also have a role as an angiogenic factor in intratumoral vascularization in ovarian cancer carcinogenesis. It is the purpose of our proposed study to investigate the relationship between AVP expression and its vascular receptor with ovarian neoplasm histology.

Preliminary results:

Recently, our labs have isolated and analyzed human mesenteric arteries for VP mRNA and V1 receptor mRNA analyses. V1R mRNA was strongly positively correlated with diastolic blood pressure (r = 0.70, p = 0.0112). V1R mRNA tended to be greater in males than females (5.73 + 1.29 compared to 2.3 + 0.94 relative expression units of V1R mRNA, p = 0.057). Also, arterial AVP mRNA correlated negatively with age (p=0.0028). These results suggest that alterations in both VP and V1R expression could be involved in disease states such as ovarian cancer where blood pressure and flow as well as age may be factors in the development of the malignancy of the tumor.

The AVP peptide was measured by radioimmunoassay in other blood vessels23, e.g. radial and mammary artery and saphenous vein samples, and the immunoactivity was shown to co-migrate with synthetic AVP on HPLC analysis. The levels of hormone ranged from undetectable to as high as 60 uU/gr tissue. Thus, we will also be able to verify changes in VP gene expression by measuring the AVP protein directly in the ovarian neoplasm blood vessels collected.

6. PLAN: Women, 18 years old or greater, who are having their ovaries removed will be enrolled in the protocol. 110 total specimens will be obtained. At our institution approximately 200 patients per year have ovaries removed. All patients who have had gynecologic tissue removed for benign (non cancerous) or malignant (cancerous) indications will meet inclusion criteria. Patients who have a malignancy that is not a primary gynecologic malignancy will be excluded from the study. Each patient's intratumoral vascularity will be assessed by Doppler ultrasound and systemic blood pressure measured preoperatively.

PROCEDURE FOR PROCUREMENT, PREPARATION AND SHIPMENT OF TISSUE SPECIMENS Ovarian arterial and venous specimens will be collected for analysis of AVP peptide and for AVP and vasopressin receptor mRNA. Operating room personnel will be asked to keep the tissue, ovarian artery and vein segments, fresh and not put it in fixative. Promptly following removal of the tissue, the specimens will be prepared as follows: The most sterile primary tissue will be cut to measure at least 5.0 cm in length. The tumor tissue will then be separated from as much connective tissue as possible. The specimen will be placed in the RNA preservative RNAlaterTM, placed on wet ice and sent to the Department of Clinical Investigation Laboratories quickly. Laboratory analyses of AVP peptide and for AVP and vasopressin receptor mRNA isolation and quantitation will be performed in the Physiology and Research Pharmacology laboratories of the Department of Clinical Investigation.

Laboratory Methods: Vasopressin synthesis (as indicated by VP mRNA) and vasopressin receptor (V1R or V2R) up or down regulation (as indicated by V1R mRNA or V2R mRNA levels) will be assessed. Measurement of V2R in addition to V1R mRNA will help clarify whether possible changes in V1R expression in the ovarian neoplasms are specific to that receptor subtype. Ovarian artery samples will be isolated and stored in RNA later TM (Ambion, Austin, TX) at -70oC until extracted for RNA with a commercial kit (Invitrogen Carlsbad, CA). VP mRNA, V1R mRNA, and beta actin mRNA will be quantified by quantitative real-time PCR (qPCR) using an iCycler (BioRad Laboratories, Hercules, CA). Reverse transcription of the RNA to cDNA will be done using Superscript TM (Invitrogen), and PCR will be done with Platinum qPCR SuperMix-UDG (Invitrogen). Standard curves will be generated using dilutions of a stock of human blood vessel cDNA and the cycle threshold for each sample will be related to a dilution's assigned copy number. qPCR data will be expressed as a ratio of VP, V1R, or V2R mRNA copies per beta-actin mRNA copies. Product generation on all three mRNA segments we are measuring, yield slopes of approximately 3.3 indicating nearly 100% efficiency of a doubling of product with each cycle in temperature, and gel electrophoresis indicates one band of product. All quantitation is done through the detection of increasing intensity of a specific fluorescent probe for each product.

Vasopressin peptide will be analyzed by radioimmunoassay of vascular tissue extracts. The tissue will be extracted by first rinsing the tissue free of blood with 0.1 N Acetic Acid, blotting and weighing the tissue. The specimen will placed in cold 1.0 N HCl (1ml/0.5 g tissue) and homogenized with a Polytron for 1 min. The homogenate will then be centrifuged at 27,000 G for 45 min. The supernatant will be saved, and the pellet resuspended and rehomogenized in 1 ml 1.0 N HCl, and centrifuged. The supernatants are then combined. The supernatants will then be extracted as routinely done with plasma samples by absorption on to octadecylsilane cartridges (SepPak, C-18, Waters, Milford, MA) and eluted with acidified ethanol. The eluate is dried by vacuum and suspended in assay buffer. At this point the sample can be applied to C-18 HPLC column and eluted in a single phase buffer system consisting of 0.05 M NH4AC in 39% MeOH, and each 1-ml fraction, dried under vacuum, and suspended in radioimmunoassay buffer and assayed. Alternatively, the HPLC fractionation may not have to be done after initial confirmation that no interference is present in the initial sample. In this case, the initial extract will be assayed by radioimmunoassay directly.

Evaluation of Vasopressin in the Vessels of Ovarian Neoplasms

Evaluation of Vasopressin and Vasopressin Receptor Expression in the Arteries and Veins of Ovarian Neoplasms

United States Department of Defense

Myoma

Neoplasms, Connective Tissue

Connective Tissue Diseases

Pharmaceutical Solutions

Respiratory System Agents

Epinephrine

Racepinephrine

Epinephryl borate

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

In the epinephrine group, we used a dilute epinephrine, 0.5 mg of epinephrine (\[1/2\] vial of 1mg/mL) in 50 mL of saline solution, taking care to use no more than 20 mL of solution per a subject.

In the vasopressin group, a dilute vasopressin, 5 units in 50 mL of saline solution, taking care to use no more than 20 mL of solution per a subject was injected.

Uterine myomas (fibroids or leiomyomas) are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. Although hysterectomy is the definitive treatment of myomas, myomectomy remains the gold standard treatment for women desiring future fertility and uterine conservation3. However, bleeding is often a problem in myomectomy and can results in intraoperative hypovolemic shock, postoperative anemia, pelvic infection, and adhesions with infertility.

A number of interventions have been introduced to reduce hemorrhage during myomectomy. Two categories of interventions can be identified: (a) Vascular interventions on uterine and/or ovarian arteries such as artery clamping, tying, or embolization; (b) pharmacologic interventions such as vasopressin, epinephrine, oxytocin, ergometrine, misoprostol, sulprostone, and gonadotropin-releasing hormone (GnRH) agonist4-11. Of these, intraoperative local injection of vasopressin causing vasospasm is most commonly used. However, there is not a wide consensus on the use of this agent because of serious side effects reported in literature. In addition, in several countries, including France and Italy, vasopressin has not been commercialized because of its potential adverse effects on cardiovascular system.

Epinephrine also induces a vasoconstrictive effect on tissue that lasts longer than that of vasopressin (5-6 hours versus 7-35 minutes) and is used during various gynecological surgeries, endoscopic resection, and dermatologic procedures to reduce blood loss. However, there are a few studies for the use of epinephrine to reduce hemorrhage during myomectomy. Furthermore, a randomized comparison of epinephrine and vasopressin as hemostatic agents during myomectomy has never been conducted. To test the hypothesis that the injections of epinephrine and vasopressin during myomectomy are equivalent in reducing blood loss, the investigators performed this randomized controlled study.

Vasopressin Versus Epinephrine in Myomectomy

Use of Vasopressin Versus Epinephrine to Reduce Hemorrhage During Myomectomy: a Randomized Controlled Trial

The operative blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery.

CHA University

Professor

During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 50 ml of normal saline to make a total of 100 ml) was injected before uterine serosal incision.

During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 200 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.

During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 400 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.

During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.

Hee Seung Kim, MD/PhD

The purpose of this study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy.

This study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy. We would like to evaluate the feasibility and validity of this study for future Phase III randomized clinical trials through this preliminary randomized assignment study.

Uterine fibroids are the most common tumors in women, and uterine myomectomy, which is performed as a treatment for them, is basically a high risk of bleeding and blood transfusion. A common method to reduce intraoperative bleeding is to inject diluted vasopressin into the subserosal areas of the fibroids. However, no proper level of vasopressin dilution has been determined so far, so we want to determine an effective dilution concentration of vasopressin that can minimize side effects through this clinical trial.

Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy

Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study

The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle

Time from anesthesia start to delivery of patient to recovery room

Whether patients are transfused during admission period Number of units transfused red blood cell

The amount of fluid injected during operation

Seoul National University Hospital

Associate Professor

Digestive System Diseases

Neoplasm Metastasis

Colonic Neoplasms

Neoplastic Processes

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Hematinics

Herbal and Botanical

Liver Extracts

Cola

Patients will be treated with Empressin® 0.8 U/ml, 0.056 ml/kg/h during surgery.

Patients will receive normal saline 0.056 ml/kg/h during surgery.

Infusion of Argipressin 0.8 U/ml, 0.056 ml/kg/h will be started as soon as the central line is placed, and continued until the end of surgery in the treatment arm.

Argipressin

Infusion of Normal Saline 0.056 ml/kg/h will be started as soon as the central line is placed, and continued until the end of surgery in the placebo arm.

Placebo

Ellinor Wisen, MD

kristina svennerholm, MD PhD

Kristina Svennerholm, MD PhD

Ellinor Wisén, MD

Kristina Svennerholm, MD, PhD

Andreas Kvarnström, MD, PhD

Lena Sand, MD, PhD

Magnus Rizell, MD, PhD

Infusion of Argipressin during hepatic resection surgery may reduce blood loss. It may also reduce transfusion requirements, and mitigate the perioperative inflammatory response compared to placebo. Subjects will be randomized to infusion of Argipressin or placebo during surgery. Blood loss, transfusion requirements, surgical data including length of stay in hsopital, inflammatory markers and markers of renal- intestinal- and cardiac injury will be assessed.

Hepatic resection is a major surgical intervention with high risk of substantial blood loss. The surgical means to reduce blood loss may impair perfusion and induce intestinal congestion. If blood flow to the liver can be influenced by pharmacological means, blood loss and transfusion requirements may be reduced. Moreover, the inflammatory system is involved in cancer development, and the anti-inflammatory properties of Argipressin may decrease the inflammatory response after hepatic surgery.

Argipressin is an endogenous substance, and part of the body's response to stress and trauma. Argipressin affects V1-receptors to produce vasoconstriction. It is also involved in inflammatory reactions and affects platelets.

Patients will be stratified according to planned type of surgery (open/laparoscopic) and planned extent of resection, and randomized to etiher infusion of Argipressin or placebo (normal saline) during surgery. In all other aspects, the participants will be treated according to the institution protocol for hepatic resection. The study drug will be started as soon as the central line is placed, and discontinued at the end of surgery. Hemodynamic data will be collected during surgery, and blood and urine-samples will be obtained during and after surgery for analysis of inflammatory markers and markers of organ injury.

Singel center double-blinded, randomized, placebo-controlled trial.

Randomisation will be handled by a nurse not involved in the study, and both the patient, treating physician and nurse, the study nurse and the investigators will be blinded to the study treatment.

Argipressin's Influence on Blood Loss During Hepatic Resection

Influence of Argipressin on Blood Loss During Hepatic Resection; a Double-blinded, Randomized Placebo-controlled Trial (ARG-01)

Metadata will be shared by the Swedish National Data Service (SND, https://snd.gu.se/en) and selected psedonymised data will be made available on reasonable request, after proper confidentiality and ethics assessment. As the study is still ongoing, the extent of data made available will be decided after study closure, and also the time span for availability.

Blood loss at the end of surgery, measured according to the investigator's instructions, by visual assessment of suction devises and gauze, and subtraction of ascites and irrigation fluids.

Blood transfusion (ml) at the end of surgery and at postoperative day 1 and 2 and 5 respectively.

Levels of White Blood Cell count, C Reactive Protein, Platelet count and Albumin at the end of surgery and postoperative day 1-5

Levels of Interleukin (IL)-1 Beta, IL-6, IL-8, IL-10, Monocyte chemoattractant protein-1, Stromal Cell-Derived Factor-1 alpha, Intercellular Adhesion Molecule, Complement (C) 3a, C5b-9 at the end of surgery and postoperative day 1 and 2.

duration of Pringles manouvre (min), duration of resection phase (min) and surgery (min)

achievement of CVP (central venous pressure) goal (mmHg), as recorded on the Phillips monitor.

Total use of noradrenaline (micrograms/minutes of surgery/ bodyweight)

Postoperative complications including death and radicality of resection at 30-day follow up.

Change in plasma creatinine (micro-mole/L)

Change in urine creatinine and urine \[TIMP-2\] x \[IGFBP-7\] (quota, no unit)

Kristina Svennerholm

Principal investigator, MD, PhD

Vasodilator Agents

Platelet Aggregation Inhibitors

Urological Agents

Alprostadil

20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation.

20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy

prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy

one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe. Needle was inserted through the working channel of the hysteroscope until its tip was seen. The needle tip was pointed to the site of injection under hysteroscopic guidance during the whole injection technique. Aspiration was done first to avoid intravascular injection of vasopressin. The diluted solution was injected into the surface, especially to parts with dilated vasculature till they blanch.

A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .

This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .

Yes: Eligibility is based on gender, As the subject of the study is hysterscopic myomectomy so the the clinical trial is based on female gender

Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.

Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients	NCT01718613	Septic Shock	Vasopressin Norepinephrine	18 Years -	Instituto do Cancer do Estado de São Paulo
Combined Vaginal Misoprostol and Perivascular Vasopressin	NCT03815344	Leiomyoma Laparoscopy Uterine Myomect...	Standard Standard-vagina...	18 Years - 55 Years	Maimonides Medical Center
Evaluation of Vasopressin in the Vessels of Ovarian Neoplasms	NCT00160472	Ovarian Neoplas...	removal of ovar...	18 Years -	Tripler Army Medical Center
Vasopressin Versus Epinephrine in Myomectomy	NCT01861015	Uterine Myomas	Epinephrine Vasopressin	18 Years - 75 Years	CHA University
Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy	NCT04874246	Uterine Leiomyo...	Vasopressin	19 Years - 60 Years	Seoul National University Hospital
Combined Vaginal Misoprostol and Perivascular Vasopressin	NCT03815344	Leiomyoma Laparoscopy Uterine Myomect...	Standard Standard-vagina...	18 Years - 55 Years	Maimonides Medical Center
Vasopressin Versus Epinephrine in Myomectomy	NCT01861015	Uterine Myomas	Epinephrine Vasopressin	18 Years - 75 Years	CHA University
Argipressin's Influence on Blood Loss During Hepatic Resection	NCT05293041	Colon Cancer Li... Inflammatory Re... Vasopressin Cau...	Argipressin Placebo	18 Years -	Sahlgrenska University Hospital, Sweden
Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.	NCT03930069	Submucous Leiom...	Misoprostol Vasopressin	18 Years - 40 Years	Zagazig University

Spots Global Cancer Trial Database for vasopressin

Every month we try and update this database with for vasopressin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vasopressin

Every month we try and update this database with for vasopressin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vasopressin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.