Effect of Nutritional Support on Liver Integrity during General Anesthesia for Laparoscopic Cholecystectomy.A Pilot Study - Nutritional support and liver
- Conditions
- To the best of our knowledge, there is no clinical study on the protective effect of nutritional support on the liver in the perioperative setting using clinical and biological variables. Regarding this fact, we propose to evaluate the effect of the N4-550E Oliclinomel solution, on hepatic integrity in fasting surgical patients during elective laparoscopic surgery.
- Registration Number
- EUCTR2006-000164-93-BE
- Lead Sponsor
- Department of Anesthesiology University Hospital Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
male and female patients between 18 and 75 year old, with Body Mass Index (BMI) < 30 kg/m2, able to read and understand French, with normal mental health, scheduled for elective laparoscopic cholecystectomy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients will be primarily excluded from the study if they suffer instability of vital functions, cancer, chronic endocrine diseases (diabetes mellitus, thyroid dysfunction, etc), neurological diseases, acute or chronic liver disturbances (control of Quick, bilirubin or transaminases), renal insufficiency (creatinine clearance < 50% of normal), congestive heart failure, glucocorticoid and/or catecholamine therapy, fever, gastrointestinal diseases and patients with alcohol or drug abuse; furthermore patients having received chemotherapy, hepatotoxic drugs, TPN in the preceding 15 days, or having undergone an operation in the preceding 30 days. Pregnant patients, inborn errors of amino acid metabolism as well as patients with history of severe drug hypersensitivity or allergic diathesis to egg proteins and soybean will be excluded as well. Bleeding during surgery with a transfusion need of more than 2 units of red blood transfusion and/or 4 units of fresh frozen plasma will lead to exclusion from the study. Serious adverse drug reactions, violation of the study protocol (e.g. infusion of less than 85% of the planned volume), the development of severe organ failure, or the need for surgical reintervention are defined as secondary exclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method