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.
Conditions
Interventions
Trade Name: Oliclinomel N4-550 E
Product Name: OliClinomel N4-550E
Product Code: 3BF0F1B79
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of
Sponsors
Department of Anesthesiology University Hospital Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male and female patients between 18 and 75 year old, with Body Mass Index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. The N4-550 E OliClinomelÒ solution (Baxter, Lessine, Belgium) is a TPN product consisting in a triple compartment plastic container: one compartment contains a lipid emulsion, one compartment contains the aminoacids solution with electrolytes, and the third compartment contains a glucose solution with calcium. will be purchased from Baxter (Brussels, Belgium). This solution is routinely used for TPN in critical care.;Secondary Objective: ;Primary end point(s): 1. Demography; 2. ASA and Hunt scores; 3. Daily alcohol consumption and smoking habit; 4. Medical history and medications; 5. VAS score for pain and nausea; 6. Anxiety on a 4-point-scale; 7. Duration of preoperative fasting; 8. Duration of anesthesia and surgery; body temperature; 9. Anesthetic drugs consumption; 10. Blood loss; 11. Type and quantity of additional fluids or transfusion given during surgery; 12. Minor or major events during the surgical procedure; 13. Analgesic and antiemetic drug consumption during the postoperative period; 14. Type and quantity of fluids given as well as liquids and food intake during the study period; 15. Postoperative nausea and vomiting (PONV); 16. Thirst and hunger (yes/no); 17. Postoperative complications and adverse events; 18. Patient’s satisfaction on a 4-point-scale; 19. Length of hospital stay. The aspartate aminotransferase (AST, I.U./l), alanine aminotransferase (ALT, I.U./l), lactate dehydrogenase (LDH, I.U./l), g-glutamyltransferase (gGT, I.U./l), alkaline phosphatase (ALP, I.U./l), glucose (mg/dl), lactate (mg/dl), ions (mEq/l), protein (g/l), albumin (g/l), urea (mg/dl), aPTT, TCA, | — |
Countries
Belgium
Outcome results
None listed