Health Condition 1: K85- Acute pancreatitis
Conditions
Interventions
Intervention1: Omega 3 Fatty Acid Intravenous supplement: Daily administration of intravenous (IV) preparation of ?-3 Fatty Acids as infusion over 4 hours after randomization for 1 week at a dose of
Sponsors
AIIMS NEW DELHI
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients with a diagnosis of acute pancreatitis as per the revised Atlanta definition 2. Age >18 years and 3. Hospitalized within 14 days of onset of illness. 4. Persistent ( >48 hours) primary organ failure due to acute pancreatitis of any of the 3 systems (respiratory, renal and cardiovascular) as per the revised Atlanta classification
Exclusion criteria
Exclusion criteria: 1. Hypertriglyceridemia (TG >500 mg/dL) 2. Grade 4 organ failure as per modified Marshall’s score 3. Secondary organ failure due to sepsis 4. Pregnancy 5. Coexistent disease condition with poor survival 6. Acute Liver Failure 7. Known Hypersensitivity to fish or egg 8. Patient already on total parenteral nutrition 9. Refusal to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in organ failure as assessed by a reduction in baseline modified Marshall’s score by at least 1 point (score ranges from 0- 4) assessed two weeks after the last dose of ?-3 Fatty Acid.Timepoint: Improvement in organ failure as assessed by a reduction in baseline modified Marshall’s score by at least 1 point (score ranges from 0- 4) assessed two weeks after the last dose of ?-3 Fatty Acid. | — |
Secondary
| Measure | Time frame |
|---|---|
| MortalityTimepoint: at 30 days;A sub-group analysis of improvement in organ failure score at 2 weeks in patients with single or muli-organ failureTimepoint: at 2 weeks;Total duration of ICU and hospital stayTimepoint: At Discharge;Need for mechanical ventilation and dialysisTimepoint: During admission;Development of local complications including (peri)pancreatic necrosis and infected pancreatic necrosis (IPN)Timepoint: During admission;Change in inflammatory markers including C-reactive protein levels and serum cytokines such as IL -1 ? , IL-2, IL-6, IL-8, IL-10, IL-12, IL-17, IL-18, TNF-a, IFN ? and free fatty acid levels prior to supplementation, on day 8 and day 14 of the studyTimepoint: At day 8 , 14 | — |
Countries
India
Contacts
Public ContactDR RAJESHWARI SUBRAMANIAM
AIIMS, Delhi
Outcome results
None listed