Symptoms and General Pathology

All Conditions

Infections

Critical Illness

Sepsis

Toxemia

Herbal and Botanical

All Drugs and Chemicals

Kava

OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 A technique for the non-invasive determination of SV, CO, cardiac index, stroke index and HR along with other hemodynamic parameters such as preload (Thoracic Fluid Index), afterload and others.

The changes of impedance over time are integrated in a complex algorithm that allows to measure CO and the other above-mentioned parameters.

Based on its precedent electrical impedance. 4 electrodes are placed on the patient: 2 on the left of the neck and the other 2 on the left lower chest . A low magnitude (2 mA), high frequency (30-100 KHz) alternating electrical current (AC) of constant amplitude is applied through the outer electrodes, and the resulting voltage is received by the inner electrodes. The ratio of the detected voltage to the applied current is the bio-impedance. The principle on which this is based is that during systole, red blood cells flow in a parallel manner, which allows the electrical current to flow easily thereby improving the electrical velocity and decreasing impedance. While during diastole, RBCs are randomly arranged, consequently hindering the electrical current (increased impedance) and decreasing electrical velocimetry. The changes of impedance over time are integrated in a complex algorithm that allows to measure CO and the other parameters.

OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3

A low-frequency phased array transducer (3.5-5 MHz) will be used to assess the IVC, which lies in the retroperitoneum, to the right of aorta. At or near the junction with the hepatic veins, we will measure the IVC diameter. To properly visualise the IVC, the probe will be inserted in the subxiphoid 4-chamber position with the probe marker oriented vertically to find the right ventricle and atrium. We will see the convergence of the IVC with the right atrium as the probe is progressively aimed towards the spine. We will then follow the IVC inferiorly, to detect the meeting of the hepatic veins with the IVC. M-mode Doppler sonography of the IVC will be used to graphically document the absolute size and dynamic changes in the calibre of the vessel during inspiration and expiration. After the visualisation of the IVC, we will freeze the US screen, and using the caliper function on the US machine, maximum and minimum diameters of the IVC will be documented.

Fujifilm Sonosite M-Turbo C Ultrasound system

Mohamed A Gaafar, MBBCh. MSc

43 patients between 18-60 years presenting with criteria of sepsis (life-threatening organ dysfunction caused by a dysregulated host response to infection, suspected or documented infection and an acute increase ≥2 SOFA \[Sequential Organ Failure Assessment\] points) will be enrolled in our study. Approval of the ethical committee and informed written consent from first degree relatives will be issued. They will be given a full and detailed explanation of the intended study protocol and will be informed about the potential benefits of the development of a successful technique as well as the potential side-effects.

To compare the efficacy of non-invasive cardiometry and ultrasound (US) guided inferior vena cava (IVC) collapsibility when assessing the response of septic patients to fluid therapy guidelines of The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); in the first six hours of ICU admission .

One of the newer non-invasive methods used to assess fluid status has been the IVC collapsibility index (IVC CI) - which has shown encouraging results as a guide to fluid therapy. Studies have shown that there is an increase in CVP and decrease in IVC collapsibility with fluid replacement, as well as that both are affected by changes in intrathoracic pressure and right heart dysfunction.

measurement of (IVC CI) is calculated by ultrasound through maximum IVC diameter - minimum IVC diameter divided by minimum diameter then multiplied by 100.

if it is less than 50% means that the patient is volume non- depleted while if it is more than 50% means the reverse.

The other recent non-invasive monitoring tool is electrical cardiometry. Its idea is based on electrical impedance. The variations in impedance are calculated using an algorithm that allows measurement of the CO as well as other key haemodynamic parameters including preload (Thoracic Fluid Index), afterload (systemic vascular resistance, SVR). This has helped provide a sound guide to each individual patient's response to fluid therapy and selection of the proper cardiovascular medications and support.

To compare the efficacy of non-invasive cardiometry and ultrasound (US) guided inferior vena cava (IVC) collapsibility when assessing the response of septic patients to fluid therapy guidelines of The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); in the first six hours of ICU admission .

Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness

Evaluation of Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness in Septic Cancer Patients

The ultrasound guided IVC collapsibility index will be correlated with to the cardiac index determined by the non-invasive cardiometry to determine which is more effective.

National Cancer Institute, Egypt

Principal Investigator

Disease Attributes

High Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol

Standard Protein Diet (1,0 - 1,2g/Kg body weight/day) Physical Activity protocol

Enteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day

Intervention

Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day

Control

Juliano P Almeida, Professor

Ilana Roitman, RD

Juliano P Alemida, Professor

Ilana Roitman

This is a Randomized Controlled Trial . The purpose of this study is to assess the hypothesis that whether a high protein diet combined with a physical activity protocol in surgical cancer patients admitted to the ICU in the post operative period is associated with better physical function at the hospital discharge as well as a better quality of life.

Surgical cancer patients will be categorized by their nutritional risk using a specific screening toll. During the hospital stay some measurements will be done. Such as resting energy expenditure (REE) before and after surgery; physical function evaluation; strength and quality of life.

The proposed intervention is a post operative diet with a different amount of protein (diet with a standard amount of protein and a diet with high amount of protein) associated to an institutional protocol of physical activity.

Protein Intake Associated With Physical Activity Related to Specific Outcomes

The Efficiency of Different Amount of Protein Intake Associated With a Physical Activity Protocol in Surgical Cancer Patients Admitted to the Intensive Care Unit : Randomized Controlled Trial

6-minute walk test after 30 days the date of randomization;

Measurement of quality of life using the Euro-Qol 5D-5L index. EQ-5D-5L index includes five questions concerning mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A summary utility index value can be computed from subject's response to these five questions. Values range from -0.594 (worst possible health score) to 0 (death) to 1.000 (best health).

Starts in the first day of hospitalization and ends on the day of hospital discharge

University of Sao Paulo

Medical Doctor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Acute Kidney Injury

Ischemia

Acute Graft Versus Host Disease

Natriuretic Agents

Spironolactone

Mineralocorticoid Receptor Antagonists

Mineralocorticoids

Hormones

Hormone Antagonists

Diuretics

Diuretics, Potassium Sparing

Spironolactone 25 mg PO daily for three days. During five days investigators will collect values of plasma creatinine, sodium, potassium, blood ureic nitrogen, vital signs and urinary output.

Placebo 25mg PO daily for three days During five days investigators will collect values of plasma creatinine, sodium, potassium, blood ureic nitrogen, vital signs and urinary output.

After a major surgery event a time 0, 24h and 48h

Placebo

Bertha M Cordova-Sanchez, MD

Silvio A Ñamendys-Silva, MD

Acute kidney injury frequently affects cancer patients. The main cause of acute kidney injury is ischemic damage caused by transient decrease in renal blood flow, followed by blood flow restoration and accompanying reperfusion injury (ischemia-reperfusion injury. Several studies, mainly in animal models have tried to establish spironolactone role on kidney injury induced by ischemia-reperfusion injury. It has been demonstrated in renal transplant recipients that the administration of spironolactone can prevent oxidative stress and is safe. The group of cancer patients with states capable of producing tissue hypoperfusion (hypovolemic shock, heart failure, major surgery, use of anesthetics) are at increased risk of developing acute renal ischemia-reperfusion injury.

The investigators hypothesis is that spironolactone may be useful in preventing acute renal injury when administered during the first six hour of renal ischemia-reperfusion insult.

The purpose of this study is to determine the utility of spironolactone administered after an ischemic renal insult (major surgery) to prevent acute kidney injury in critically cancer patients.

Investigators propose a pilot study, randomized, double blind, placebo controlled trial, approved by the local ethical committee, to compare the efficacy of spironolactone to prevent acute kidney injury in patients after major surgery. Investigators will include 12 patients in spironolactone group (25mg daily for three days) and 12 patients in placebo group.

Acute kidney injury frequently affects cancer patients, with an estimated annual risk of 17.5% after cancer diagnosis. In critically ill cancer patients, acute kidney injury incidence varies between 12 to 49%, and between 9 and 32% need renal replacement therapy. In this last group of patients, acute kidney injury frequently occurs as part of multiple organic failure and is associated with a mortality rate of 53 to 93%, as well as an increment in costs and days of hospitalization.

The main cause of acute kidney injury is ischemic damage caused by transient decrease in renal blood flow, followed by blood flow restoration and accompanying reperfusion injury (ischemia-reperfusion injury.

The decrease on renal blood flow is followed by an increment of aldosterone, this hormone acts on epithelial cells through mineralocorticoid receptors in several tissues, including heart and kidneys. In kidneys, aldosterone promotes sodium absorption and potassium excretion.

The decrease in renal blood flow is a strong stimulus for aldosterone secretion. This hormone has non-genomic actions on smooth muscle cells and vascular endothelium, causing vasoconstriction, interleukin and oxygen reactive species generation, and beta-transforming growth factor (TGF BETA) mediated fibrosis, among others.

At renal level, it has been demonstrated that mineralocorticoid receptor blockade can prevent proteinuria and glomerulosclerosis development in animal models of chronic kidney disease. Moreover, in chronic kidney disease patients with proteinuria, spironolactone addition to angiotensin converting enzyme inhibitors (ACEI), reduces proteinuria in 42% without a higher risk of hyperkalemia.

Several studies, mainly in animal models have tried to establish spironolactone role on kidney injury induced by ischemia-reperfusion injury.

In an acute and chronic cyclosporine (CyA) nephrotoxicity rat model, spironolactone administration prevented kidney injury associated to afferent arteriole vasoconstriction.

In an animal ischemia-reperfusion model produced by renal artery clipping, spironolactone administration one (Sp1), two (Sp2) or three (Sp3) days before ischemic insult resulted in better renal plasmatic flow and creatinine clearance, and prevented histopathological ischemic lesions. Spironolactone administration stimulated nitric oxide production and prevented lipid peroxidation and caspase 3 mediated apoptotic injury.

To determine aldosterone blockade effects after ischemic injury, a new group of animals received spironolactone at 0, 3, 6 and 9 hours after IR insult. Spironolactone administration up to 6 hours after IR insult prevented histologic kidney tubular damage. KIM-1 mRNA levels did not augmented in 0 and 3 hour groups, suggesting that spironolactone administration up to three hours after renal ischemic injury prevented kidney damage.

Considering that IR injury is the principal etiologic agent on acute kidney injury in renal transplant patients, in 2013, a pilot double blinded clinical trial included 20 living kidney transplants divided in spironolactone (25mg per day) or placebo groups, receiving the drug one day before and three days after renal transplant surgery. It was observed that in spironolactone prophylactically treated patients, urinary levels of hydrogen peroxide were inferior at the fifth day compared to placebo group, however, there were no differences in serum creatinine levels nor in other urinary biomarkers (KIM-1, IL-18, HSP-72). In this trial, no patient developed potassium levels higher than 6mEq/dL and there was only one patient in each group with serum potassium higher than 5mEq/L, demonstrating that spironolactone administration was safe.

The group of cancer patients with states capable of producing tissue hypoperfusion (hypovolemic shock, heart failure, major surgery, use of anesthetics) are at increased risk of developing acute renal ischemia-reperfusion injury.

The investigators hypothesis is that spironolactone may be useful in preventing acute renal injury when administered during the first six hour of renal ischemia-reperfusion insult.

The purpose of this study is to determine the utility of spironolactone administered after an ischemic renal insult (major surgery) to prevent acute kidney injury in critically cancer patients.

Investigators propose a pilot study, randomized, double blind, placebo controlled trial, approved by the local ethical committee, to compare the efficacy of spironolactone to prevent acute kidney injury in patients after major surgery. Investigators will include 12 patients in spironolactone group (25mg daily for three days) and 12 patients in placebo group. During five days investigators will collect values of plasma creatinine, sodium, potassium, blood ureic nitrogen, vital signs and urinary output.

Spironolactone Administration to Prevent Ischemic Kidney Injury in Critically Ill Cancer Patients

Elevation of creatinine to 0.3mg/dL above baseline in the last 48 hours

Elevation of baseline creatinine 1.5 times above baseline

Decreased urine output less than 0.5ml/kg/hr over a period of 6 continuous hours somewhere during the first 48 hours monitoring, after admission to the intensive care unit

Instituto Nacional de Cancerologia de Mexico

Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Mouth Neoplasms

Hypopharyngeal Neoplasms

Pharyngeal Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Oral Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Central Nervous System Depressants

Cardiotonic Agents

Metoclopramide

Ethanol

Dopamine

Dopamine Antagonists

Dopamine Agents

Neurotransmitter Agents

In addition to routine ICU treatments, patients in the specific acupuncture group will also receive daily bilateral traditional Chinese medicine style acupuncture on the following acupuncture points: ST36 (Zu San Li), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Nei Guan) and LI4 (He Gu). The acupoints indications in this group are specific to treat indigestion related conditions. The treatment will take place once a day, over three days, for a total of three treatments. A total of 10 Needles will be used in each session Acupuncture treatment will be performed with sterile needles manufactured by "Yu Kuang" acupuncture needles 40mm with 30G.

Acupuncture doctor will disinfect the acupoints with alcohol and will perform acupuncture on the marked points with needle Needle retention time will be 30 minutes. The needles will be withdrawn by acupuncture doctor.

Patients' in the non-specific acupuncture group (Con-Acu) will receive routine ICU treatment as well as a total of 3 daily non digestion related Traditional Chinese medicine style acupuncture treatments at the following acupoints: LI 15 (Jianyu), SJ 14 (JianLiao) LU3 (Tianfu), GB35 (Yangjiao), BL 59 (Fuyang). The selected control points are not indicated for the treatment of digestion related pathologies, and are not reported to improve digestive function.

Acupuncture doctor 1 will disinfect the marked acupoints with alcohol and will perform acupuncture on the marked points. Needle retention time will be 30 minutes. The needles will be withdrawn by acupuncture doctor

In addition to routine ICU treatments, patients in the specific acupuncture group will also receive daily bilateral traditional Chinese medicine style acupuncture on the following acupuncture points: ST36 (Zu San Li), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Nei Guan) and LI4 (He Gu). The acupoints indications in this group are specific to treat indigestion related conditions. The treatment will take place once a day, over three days, for a total of three treatments. A total of 10 Needles will be used in each session Acupuncture treatment will be performed with sterile needles manufactured by "Yu Kuang" acupuncture needles 40mm with 30G.

Specific acupuncture group

Patients in all groups will receive Metoclopramide 10mg/ per 8 hours in the case of poor digestion, alongside the individualized drug treatment prescribed by the ICU medical doctor as per individual patient needs.

Metoclopramide 10mg

Patients' in the non-specific acupuncture group (Con-Acu) will receive routine ICU treatment as well as a total of 3 daily non digestion related Traditional Chinese medicine style acupuncture treatments at the following acupoints: LI 15 (Jianyu), SJ 14 (JianLiao) LU3 (Tianfu), GB35 (Yangjiao), BL 59 (Fuyang). The selected control points are not indicated for the treatment of digestion related conditions, and are not reported to improve digestive function.

Non-specific acupuncture group

Pei-Yu Kao, M.D.

Background: Head and neck cancer patients are in high risk to suffer from malnourishment, a risk that increase in postoperative condition and with the use of enteral nutrition (EN). Until now patients who are suffering from indigestion in the ICU received treatment in the form of prokinetic drugs, drags that can lead to serious side effects and only can partially improve digestion. Acupuncture was used successfully in several clinical trials to improve postoperative indigestion in cancer patients without any reported adverse events. This study aims is to design a double blind settings in order to investigate acupuncture effect in combination of prokinetic drugs in the prevention of indigestion in postoperative oral and hypo-pharyngeal cancer patients in the Intensive Care Unit (ICU).

Methods: Single center, double blind randomize control trial will compare between two equal groups. A total of 28 patients that will meet the inclusion criteria: Age 30-80, Post plastic surgery for oral cancer or hypo-pharyngeal cancer, Apache score below 20 needed EN. Patients will be randomly divided into specific acupuncture (ACU) or non-specific acupuncture (CON) for 3 treatments in 3 days by a blind acupuncturist along with prokinetic drugs. The main outcome measurement will be the amount of days a patient need to reach Total Energy Expenditure (TEE).

Expected outcome: The results will shed light on the effectiveness and safety of acupuncture in a double blind design for posts-surgery ICU cancer patients. In addition, the study presents a revolutionary double blind design that if will prove as successful might influence the way double blind acupuncture studies are performed today.

Background: Head and neck cancer patients are in high risk to suffer from malnourishment, a risk that increase in postoperative condition and with the use of enteral nutrition (EN). Until now patients who are suffering from indigestion in the ICU received treatment in the form of prokinetic drugs, drags that can lead to serious side effects and only can partially improve digestion. Acupuncture was used successfully in several clinical trials to improve postoperative indigestion in cancer patients without any reported adverse events. This study aims is to design a double blind settings in order to investigate acupuncture effect in combination of prokinetic drugs in the prevention of indigestion in postoperative oral and hypo-pharyngeal cancer patients in the Intensive Care Unit (ICU).

Methods: Single center, double blind randomize control trial will compare between two equal groups. A total of 28 patients that will meet the inclusion criteria: Age 30-80, Post plastic surgery for oral cancer or hypo-pharyngeal cancer, Apache score below 20 needed EN. Patients will be randomly divided into specific acupuncture (ACU) or non-specific acupuncture (CON) for 3 treatments in 3 days by a blind acupuncturist along with prokinetic drugs. The main outcome measurement will be the amount of days a patient need to reach his Total Energy Expenditure (TEE).

Expected outcome: The results will shed light on the effectiveness and safety of acupuncture in a double blind design for posts-surgery ICU cancer patients. In addition, the study presents a revolutionary double blind design that if will prove as successful might influence the way double blind acupuncture studies are performed today.

Other information: The study will be conducted in the surgical ICU department, of china medical university hospital, Taichung 404, Taiwan. The study in conducted on stable ICU patients and is anticipated to have a minimum risk for adverse events. Patients enrollment and data collection will start immediately after china medical hospital research ethics committee approval. The study expected completion time: June 2021

two groups, randomized, pre-post intervention study

Patients will be randomized to one of two groups: Acu/ Con in a 1:1 ratio. The random number and patient name will be written down on an non transparent envelope by a study nurse. The study nurse will provide an envelope containing a sheet depicting the acupoint name, location and picture (Acu / Con) to the acupuncture doctor. Acupuncture doctor (blind) will preform acupuncture on the points. 30 minutes after needle insertion, acupuncture doctor will withdraw the needles. Acupuncturists, ICU nurses, ICU doctors, researchers and statisticians will all be blind to group allocation and to the meaning of the random numbers until all acupuncture treatments have been completed.

Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients

Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients: A Protocol for Double Blind Randomized Control Trial

Number of days in takes for each patient to achieve the Total Energy Expenditure

Secondary outcomes measures are the amount of prokinetic drugs prescribed by the ICU doctor in total dosage

After 5 days of conservative treatment for the poor digestion (naso-gastric tube drainage of more than 500ml per day or severe diarrhea of more than 1000 ml per day)

In patients who cannot digest with daily naso-gastric tube drainage of more than 500ml per day or severe diarrhea of more than 1000 ml per day

Incidents of vomits in total number of times and volume in micro liters

Patient's Albumin blood levels will help to assets patient's nutrition status

A day of mechanical ventilation is at least 6 hours of mechanical ventilation in one day

In case of mortality ,total mortality will be compered between the two groups

Incidents of diarrhea in number of times and volume in micro liters

No stool passage in 3 days will be considered as constipation

Incidents of nausea in number of times , measured by patient complains

Positive occult blood test of the naso-gastric tube drainage and in the stool

Body temperature more than 38 degrees Celsius

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness	NCT05104528	Volume Overload Tissue Perfusio...	OSYPKA Medical ... Fujifilm Sonosi...	18 Years - 60 Years	National Cancer Institute, Egypt
Protein Intake Associated With Physical Activity Related to Specific Outcomes	NCT03438201	Cancer Critically Ill Surgery	Intervention Control	18 Years -	University of Sao Paulo
Spironolactone Administration to Prevent Ischemic Kidney Injury in Critically Ill Cancer Patients	NCT02531412	Critically Ill Cancer	Spironolactone Placebo	18 Years - 80 Years	Instituto Nacional de Cancerologia de Mexico
Protein Intake Associated With Physical Activity Related to Specific Outcomes	NCT03438201	Cancer Critically Ill Surgery	Intervention Control	18 Years -	University of Sao Paulo
Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients	NCT03934294	Oral Cancer Hypopharyngeal ...	Specific acupun... Metoclopramide ... Non-specific ac...	30 Years - 80 Years	China Medical University Hospital
Protein Intake Associated With Physical Activity Related to Specific Outcomes	NCT03438201	Cancer Critically Ill Surgery	Intervention Control	18 Years -	University of Sao Paulo

Spots Global Cancer Trial Database for critically ill