Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Subject receives normal fluid volume during peri-operative period

Subject receives a reduced fluid volume during the peri-operative period

Normal fluid group will receive lactated ringes at 8 cc / Kg/ hr total

Normal fluid volume

Subject receives 80 cc/ hr LR during the peri-operative period

Reduced fluid volume

Lucci Stocchi, MD

Subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery.

The purpose of this study is to evaluate the impact of reduction in the amount of perioperative fluids on postoperative morbidity, postoperative recovery and the duration of hospitalization. The study will accrue patients undergoing elective open intestinal resection for benign and malignant conditions of the small and large bowel. Patients, who consent to the study, will be randomized at the time of consent, preoperatively. The primary study endpoint will a composite of mortality and major morbidity within the first 30 postoperative days. Secondary endpoints will be return to bowel function (flatus or bowel movement), postoperative hospital stay including the day of surgery and a composite of minor complications. Approximately 186 patients will participate in the study, 93 in each group. Patients will be randomized into one of two groups: the Restricted Fluid Regimen group and the Normal Fluid Administration Regimen group. A very specific flow chart for each group will be followed to distinguish the group. A research nurse will collect the data needed for the study on a daily basis. The patient will be managed by the primary surgeon and his team and the study group flow chart will be followed. If for medical reasons, the patient's care needs to be varied from the study, this is allowed, and will be documented for the study purposes.

Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes

Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery

Reduction in post-operative complications at the time of hospital discharge after the surgical episode

The Cleveland Clinic

Rare Diseases

Esophageal Neoplasms

Postoperative Complications

Esophageal Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Cardiotonic Agents

Anesthetics

Norepinephrine

Oxymetazoline

Phenylephrine

Dobutamine

Fluid and inotropic drugs are given based on conventional parameters such as blood pressure and heart rate as judged by the individual anesthesiologists judgement.

Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised

Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised

1. Crystalloid infusion (2,5 ml/kg/t) throughout surgery
2. 3 ml/kg Volulyte (synthetic colloid) is infused during 5 minutes and SV is measured directly before and 5 minutes after. If SV increases more than 10% the dose is repeated until no increase \> 10% is observed. A new dose is given if SV decreases more than 10% from the last value.
3. If despite optimal filling Cardiac Index (CI) is below 2,5 l/min/m2 infusion with dobutamin is started to attain CI \> 2,5.
4. If despite CI \> 2,5 Mean Arterial Pressure \<65 mmHg vasopressor (phenylephrine / norepinephrine) is started until MAP equals or is over 65.

fluid optimisation

Lena Nilsson, MD PhD

Surgery for cancer of the esophagus is associated with a high risk of postoperative complications. It has been shown that the risk of postoperative complications can be decreased by optimising the amount and type of infusion fluids given during surgery, steered by measurement of cardiac stroke volume, mostly done with a device called esophageal Doppler. This device can however not be used during this type of surgery. This study wants to test the hypothesis that postoperative complications in patients operated for esophageal cancer can be partially prevented by using a goal directed strategy for the administration of fluids and drugs influencing the heart and vessels, based on measurement of stroke volume by pulse wave analysis (FloTrac).

Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection

Perioperative Goal Directed Fluid Therapy During Esophageal Resection A Prospective Randomized Controlled Open Multi-centre Trial to Study the Effect on Postoperative Complications

University Hospital, Linkoeping

MD pHd

Colorectal Neoplasms

Colonic Diseases

Rectal Diseases

Current best practice of intraoperative fluid restriction

Oesophageal Doppler-guided fluid administration

Non-invasive measurement of doppler-derived cardiovascular variables (CO, aortic flow rate). Used safely over 800, 000 times

Oesophageal Doppler

Current best practice of avoiding fluid overload by intraoperative fluid restriction

Intraoperative fluid restriction

Andrew G Hill, MBChB MD FRACS

Perioperative fluid management has been historically dictated by outdated, contradictory concepts. Excessive or inadequate fluid administration around surgery is deleterious and hence goal-directed fluid therapy using Oesophageal Doppler-derived cardiac indices is preferable to optimize tissue perfusion. Previous studies in this area have been hampered by lack of standardization in other aspects of perioperative care and none have explored the impact of individualized fluid therapy on post-operative fatigue.The investigators proposed a study involving 80 patients having open/ laparoscopic colonic surgery to investigate the effect of Oesophageal Doppler guided fluid administration intraoperatively compared to current best practice of fluid restriction. The investigators have an optimized peri-operative care pathway established at the Manukau Surgical Centre (MSC), Middlemore Hospital. All patients will be cared for under the Enhanced Recovery After Surgery (ERAS) multimodal care plan therefore ensuring that all other aspects of care besides intraoperative fluid administration remain homogenous. Outcomes will include post-operative recovery, clinical outcomes as well as physiological data with follow-up to 30 days.

Until very recently, modern perioperative fluid management has involved routine administration of large quantities of fluids during major surgical procedures, typically causing a weight increase of 3-6 kg in the early post-operative period.Several factors, including concern about preoperative dehydration, attempts to support the circulation and cardiac function after general and regional anaesthesia, prevention of blood transfusion and maintenance of adequate kidney perfusion have historically lead to excess perioperative fluid administration.

However administration of excess fluid has been shown to contribute to postoperative morbidity. It increases demand on the heart and may adversely affect postoperative cardiac function. It may also lead to increased pulmonary complications. Fluid overload may lead to oedema of the gastrointestinal tract and hence contribute to post-operative gastrointestinal paralysis, bacterial translocation and sepsis. Excess fluid also has been shown to decrease tissue oxygen tension with potential deleterious effects on anastomotic and wound healing.

Therefore, current best practice has centred on fluid restriction peri-operatively with an increased focus on the intraoperative fluid regimen. Since hypovolaemia is also associated with a myriad of adverse outcomes, a balanced perioperative intravenous fluid regimen focussing on tissue perfusion is thought to be optimal. By using the Oesophageal Doppler Monitor (ODM) as a means to non-invasively estimate intra-operative cardiac output, significant improvements in outcome have been observed in patients undergoing major orthopaedic and cardiac procedures. Previous studies in patients undergoing major abdominal surgery have demonstrated that goal-directed intraoperative fluid administration using ODM may result in improved outcomes such as reduced number of critical care admissions, reduced hospital stay and overall decreased morbidity.

In the broader context of perioperative care in colonic surgery, recent developments have included Enhanced Recovery After Surgery (ERAS) programmes- a combination of various evidence-based strategies implemented together as part of a standardised protocol to synergistically decrease post-operative fatigue and improve outcomes. These strategies include preoperative counselling, avoidance of mechanical bowel preparation, pre-operative carbohydrate loading, perioperative high-flow oxygen therapy, mid-thoracic epidural analgesia, avoidance of parenteral opioids and routine wound drainage, use of short or transverse incisions, early mobilisation, early feeding and a balanced analgesia regiment. ERAS protocols are also ideal for well-designed clinical trials as they provide a template to trial new interventions on the background of an otherwise homogenous, optimised perioperative care programme. An ERAS programme has been implemented and prospectively evaluated at Manukau Surgical Centre, Middlemore Hospital in Auckland.

In a recently published systematic review, we identified that a major short-coming of the literature in this field is the non-standardised nature of peri-operative management of the patients in these studies. Although fluid management was optimised, the other aspects of care were not optimised or even standardised, introducing the risk of significant confounding. Furthermore, none have explored the role of fluid management on post-operative functional recovery- an important metric of patient-relevant outcomes evaluating recovery beyond physiological and clinical parameters. Furthermore, none of the published ERAS programmes have used ODM as part of their peri-operative strategies. Consequently, the true impact of optimised fluid therapy within an environment of current best-practice (ERAS) is unknown.

Methods Research Design We will conduct a double-blinded, randomised controlled trial of ODM versus fluid restriction (current best-practice) in patients undergoing colonic surgery within our ERAS programme to determine whether individualising fluid administration enhances post-operative recovery, thereby improving patient outcomes.

Sample Size:

To detect a 20% improvement in recovery as measured by the Surgical recovery Score at Day 7 (based on data from our previous work), we will require 37 patients in each arm (α= 0.05, β= 0.8) Therefore, we shall aim to recruit 80 patients anticipating for possible drop-outs.

Patients will be consented and then randomised by computer generated random numbers and the opaque envelope method. All Patients will have an oesophageal probe inserted with readings not available to the anaesthetist for patients in the control group (the screen will be covered). At the commencement of anaesthesia, the patient will be randomised to receive fluid management optimised by ODM data or by standard parameters. The patients, surgeons and investigators will be blinded to the intervention. The anaesthetists will use a validated protocol for the treatment group. Measurements of cardiac indices (Cardiac Output, Aortic Flow Rate) from the ODM will be noted intraoperatively. The Oesophageal probe shall be removed at the end of surgery prior to the patient waking up. All other aspects of perioperative care will be according to our previously developed ERAS programme.

Randomised Trial of Doppler-Optimised Fluid Balance in Elective Colectomy

Prospective, Double-Blinded, Randomised Controlled Trial of Doppler-Optimised Fluid Balance in Elective Colectomy Within an ERAS Protocol

As defined using trial by Buzby et al Am J Nutr 1989 and graded according to Clavien-Dindo classification

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes	NCT01563991	Benign Neoplasm... Primary Maligna... Secondary Malig...	Normal fluid vo... Reduced fluid v...	18 Years -	The Cleveland Clinic
Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection	NCT01416077	Esophageal Canc...	fluid optimisat...	18 Years -	University Hospital, Linkoeping
Randomised Trial of Doppler-Optimised Fluid Balance in Elective Colectomy	NCT00911391	Colorectal Canc... Colectomy Surgery Perioperative C...	Oesophageal Dop... Intraoperative ...	18 Years - 90 Years	University of Auckland, New Zealand

Spots Global Cancer Trial Database for fluid

Every month we try and update this database with for fluid 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 fluid

Every month we try and update this database with for fluid 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 fluid 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.