Health Condition 1: null- Adult patients requiring parenteral nutrition after major abdominal surgery
Conditions
Interventions
Intervention1: SmofKabiven® emulsion for infusion: SmofKabiven® emulsion for infusion (Fresenius Kabi AB, Uppsala, Sweden)
Active ingredients: essential, conditionally essential and non-essential amino acids, glucose, electrolytes, soybean oil, medium-chained triglycerides, olive oil, and fish oil.
â?¢ Test product will b
Active ingredients: essential, conditionally essential and non-essential amino acids, glucose, electrolytes and soybean oil.
â?¢ Control product will be administered via central venous infusion over 4
Sponsors
Fresenius Kabi India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female or male patients of any ethnicity 2. Patient is scheduled to undergo elective major abdominal surgery including surgery for cancer and non-cancer reasons including distant metastases with completely and incompletely resectable tumors: e.g., surgery for bleeding duodenal ulcer, gastrectomy, resection of small bowel, appendectomy, splenectomy, colectomy, vascular surgery, hysterectomy, ovarectomy 3. Patient has or is scheduled to peri-operatively receive a central venous catheter for routine medical care purposes 4. MELD score >=7 and 5. Patient is expected to require PN for a minimum of 4 and maximum of 7 consecutive days 6. Patient is expected to receive >=70 % of the individual energy demand by PN for a minimum of 4 days 7. Age between 18 and 65 years 8. BMI >=16 and 9. Patient is capable to give Informed Consent 10. Informed Consent form signed by the patient or an impartial witness.
Exclusion criteria
Exclusion criteria: 1. Elective surgeries possible interfering with the parameters important in calculating the primary outcome measure: excessive hepatectomy with less than 50% of viable tissue remaining, cholecystectomy, nephrectomy 2. Patient is expected to receive more than 30% of the individual energy demand by ON/EN during the first 4 days of treatment 3. Acute organ transplantations (liver, pancreas, small bowel, kidney) 4. Patient has received PN (lipids and/ or amino acids with glucose) in the last 10 days prior to screening (the sole administration of glucose will be allowed) 5. Known or expected hypersensitivity to fish-, egg-, soybean-, olive or peanut protein or to any of the active substances or excipients 6. Severe renal impairment (creatinine clearance [CLCR] 7. INR >2.5 8. Severe liver insufficiency or total bilirubin 3-times higher than the upper limit of normal 9. Inborn error of amino acid metabolism 10. Present signs of acute pancreatitis as diagnosed by clinical features 11. High likelihood of severe and life-threatening complications related to initial measures in the attempt to control the underlying disease 12. Instable septic shock or any other highly vulnerable condition of the cardiovascular system, such as uncompensated cardiac insufficiency/congestive heart failure 13. Severe metabolic acidosis 14. Hyperhydration or fluid overload and/or pulmonary oedema 15. Uncontrolled hyperglycaemia 16. Severe hyperlipidaemia 17. Pathologically elevated serum levels of any of the included electrolytes 18. Haemophagocytic syndrome 19. Any serious or clinically relevant condition that would preclude participation in the study (in the opinion of the investigator) 20. Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during study 21. Patient is pregnant or lactating and intends to continue breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary variable: The primary safety parameter will be the relative reduction of the individual Model of End Stage Liver Disease (MELD) score at the final visit versus baseline (pre-surgery, screening visit).The MELD score is a composite score combining the officially acknowledged surrogate markers for hepatic and renal function (bilirubin, INR and creatinine, respectively). â?¢ Outcome: safety â?¢ Metric: Model of End Stage Liver Disease (MELD) score Timepoint: Final visit versus pre-surgery screening visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual total number of adverse events (AEs) Severity, seriousness, clinical relevance, relatedness and outcome of AEs Various Laboratory variables e.g. CBC, Hb, Liver function test, Renal function test etc Vital signs: blood pressure, heart rate, respiratory rate, body temperature Number of days on PN for each of the study drugs Amount of volume administered daily allowing to calculate delivered calories, fat, amino acids, and glucose Secondary outcome: Lab parameter Timepoint: Pre surgery versus final lab value | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed