Health Condition 1: null- Adult patients with gastrointestinal disorders requiring parenteral nutrition
Conditions
Interventions
Intervention1: SmofKabiven® Peripheral emulsion for infusion: SmofKabiven® Peripheral 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.
Test product will be con
referred to as â??Kabiven Peripheralâ??)
Active ingredients: essential, conditionally essential and non-essential amino acids, glucose, electrolytes and soy bean oil.
Control product will be continuously infused via use of standardised perip
Sponsors
Fresenius Kabi India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female or male patients of any ethnicity 2. Patient requires PN due to a gastrointestinal disorder or after elective major abdominal surgery (major abdominal surgery includes 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. MELD score >=7 and 4. Patient is expected to require PN for a minimum of 4 and maximum of 7 consecutive days 5. Patient is expected to receive >=70 % of the individual energy demand by PN for a minimum of 4 days 6. Age between 18 and 65 years 7. BMI >=16 and 8. Patient is capable to give Informed Consent 9. 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. Acute organ transplantations (liver, pancreas, small bowel, kidney) 3. 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) 4. Patient is expected to receive more than 30% of the individual energy demand by ON/EN during the first 4 days of treatment 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. Severe hyperlipidaemia 15. Hyperhydration or fluid overload and/or pulmonary oedema 16. Uncontrolled hyperglycaemia 17. Pathologically elevated serum levels of any of the included electrolytes 18. Haemophagocytic syndrome 19. Any serious or clinically significant condition that would preclude participation in the study (in the opinion of the investigator) 20. Patient is pregnant or lactating and intends to continue breast-feeding 21. Inadequate presentation or condition of the peripheral veins (dorsal hand, forearm, cubital veins) 22. 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 23. Skin alterations that could potentially interfere with adequate assessment of local skin reactions.
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 (value at Screening). The MELD score is a composite score combiningthe 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 including local vein and skin reactions Severity,seriousness,clinical relevance,relatedness and outcome of AEs Various Laboratory variables at Pre surgery versus final visit lab value Total daily severity score (TSS) of local vein and local skin reactions assessed from Day 1 (baseline) to last day of vein inspection Vital signs Number of days on PN for each of the study drugs, volume administered daily allowing to calculate delivered calories Timepoint: Pre surgery versus final visit lab value From Day 1 (baseline) to the last day of vein inspection | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed