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    Summary
    EudraCT Number:2006-000164-93
    Sponsor's Protocol Code Number:1000000
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-05-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-000164-93
    A.3Full title of the trial
    Effect of Nutritional Support on Liver Integrity during General Anesthesia for Laparoscopic Cholecystectomy.
    A Pilot Study
    A.3.2Name or abbreviated title of the trial where available
    Nutritional support and liver
    A.4.1Sponsor's protocol code number1000000
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDepartment of Anesthesiology University Hospital Center
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Oliclinomel N4-550 E
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOliClinomel N4-550E
    D.3.2Product code 3BF0F1B79
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeparenteral nutrition
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    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
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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, fibrinogen, creatinin (mg/dl) ketone bodies and bilirubin total (mg/dl) and direct (mg/dl), iron (Fe, µg/dl), transferrin (Tf, mg/dl), ammonium (NH4, mg/l), insulin (IU/ml), triglycerides (mg/dl) and C-Reactive Protein (CRP, mg/dl) malondialdehyde (MDA) and 4-hydroxyalkenals (HAE) and cytochrome cconcentrations will be measured in the plasma
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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