Health Condition 1: Z768- Persons encountering health services in other specified circumstances
Conditions
Interventions
Intervention1: Addaven: Addaven, concentrate for solution for infusion
a mixture of 9 trace elements
(chromium, copper, iron, manganese, iodine, fluoride, molybdenum,
selenium, zinc), One ampoule (10 mL) is added aseptically to a Three-Chamber Bag (3CB) parenteral nutrit
Sponsors
Fresenius Kabi India Pvt. Ltd
Fresenius Kabi Deutschland GmbH
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex, above or equal 18 to below or equal 65 years of age 2. A voluntarily given informed consent form (ICF) from the subject, or legally acceptable representative (in case the subject is not able) 3. Subjects from Indian population 4. Subjects with an indication for PN during the postoperative period, with an anticipated duration of 4 consecutive days subjects scheduled to undergo elective major abdominal surgery, including surgery for cancer and non-cancer reasons (e.g., oesophageal resection, gastrectomy, pancreatoduodenectomy, partial pancreatectomy, small bowel resection, colon resection surgery, etc.) 5. Body mass index above or equal to 16 or below or equal to 30 kg/m
Exclusion criteria
Exclusion criteria: 1. Subjects with known allergy or hypersensitivity to the active substances or any excipients of the study drug 2. Congestive cardiac failure, or other forms of cardiopulmonary instability, e.g., cardiac arrhythmias, conditions associated with low cardiac output, hypoxemia with or without respiratory failure, shock, or blood pressure outside its normal range 3. Acute or chronic kidney disease in need of renal replacement therapy (acute kidney injury 2-3 and/or KDIGO Chronic Kidney Disease stages 4-5) 4. Conditions with total biliary obstruction, like gallstones, cysts, cirrhosis, tumors, liver/biliary tract trauma, among others 5. Hepatic failure, defined as impaired liver synthetic and metabolic function 6. Wilson s disease 7. Known or suspected hemochromatosis, hemosiderosis 8. Known or suspected pregnancy at the time of enrollment 9. Breastfeeding mothers during the study period 10. Participation in other clinical trial(s) during this study, or within the previous 4 weeks of its start 11. Subjects with known or suspected alcohol or drug abuse 12. Subjects taking any oral supplements or any beverages containing high amounts of TEs 1 week before and during the study 13. Any other clinical condition, which, in the opinion of the Investigator, could interfere with the study protocol, or affect subjects safety in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment Treatment-Emergent Adverse Events (TEAEs adverse events (AEs) occurring after the onset of infusion of the first study drug dose till next calendar day after the last study drug dose)Timepoint: From Day 1 of Addaven infusion until one calendar day after the last infusion (i.e., Day 5 or Day 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Drug Reactions (ADRs)Timepoint: From Day 1 to Day 5/6 (one day after last dose);Vital signs, physical examination, laboratory evaluationTimepoint: Screening, enrollment and from Day 1 to Day 4; final assessment on Day 5/6 | — |
Countries
India
Contacts
Public ContactDr Sadanand Kulkarni
Fresenius Kabi India Pvt Ltd
Outcome results
None listed