Health Condition 1: K85- Acute pancreatitis
Conditions
Interventions
Intervention1: Injection Methyl prednisolone (MPS) Intravenous: Intravenous methyl prednisolone MPS 60 mg for first 3 days, 40 mg for next 2 days, and subsequent taper over next 3-5 days depending upo
if there is response, then 30 mg for next 2 days followed by 20 mg for next day7, 15mg for day 8, 10 mg for day 9 and 5mg for day 10).
Control Intervention1: Placebo: Identical looking Placebo will be
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Acute Pancreatitis as per revised Atlanta Classification. 2. Patients presenting within seven days of onset of pain. 3. Presence of any organ failure (Modified Marshal grade greater than or equal to 2) i.e. cardiovascular, respiratory or renal and APACHE II score greater than or equal to 8 or systemic inflammatory response syndrome greater than 24 hours (SIRS should be assessed at two time points greater than 6 hours apart) or BISAP score greater than 3.
Exclusion criteria
Exclusion criteria: 1. Patients with Chronic Pancreatitis 2. Pregnancy and breast feeding 3. Age less than 12 years or greater than 75 years 4. Major comorbidity such as decompensated cirrhosis, Advanced heart failure (stage D), significant lung parenchymal or airway disease with NYHA grade greater than or equal to 3, advanced chronic kidney disease (stage greater than or equal to 4), untreated HIV infection, untreated cancer. 5. Patient already on immune-suppressive therapy 6. Major psychiatry disorders such as psychosis, schizophrenia, major depression, bipolar disorder etc. 7. Uncontrolled diabetes (HbA1C greater than 8), uncontrolled hypertension (systolic blood pressure greater than or equal to 140 mm Hg and diastolic blood pressure greater than or equal to 90 mm Hg as per eighth joint national committee criteria) 8. Brain dead patient or patients with two organ failure (each grade 9. Acute cholecystitis 10. Active tuberculosis 11. Known adrenal insufficiency 12. Acute gastrointestinal bleed within last 7 days 13. Presence of disseminated intravascular coagulation (DIC) 14. Encephalopathy as defined by Glassgow Coma scale less than or equal to 9.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of resolution of organ failure within 28 days from randomization. Resolution will be defined as Modified Marshall score of one or less.Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Organ Failure resolutionTimepoint: 28 days;All Cause mortalityTimepoint: 4 weeks;Resolution of cytokine storm syndromeTimepoint: 4 weeks;Need for mechanical ventilation or hemodialysisTimepoint: 4 weeks;Duration of ICU stayTimepoint: 4 weeks;Development of infected necrosisTimepoint: 3 months;Need for drainage of collectionTimepoint: 3 months;Need for necrosectomyTimepoint: 3 months;Adverse eventsTimepoint: 28 days | — |
Countries
India
Contacts
Public ContactSoumya Jagannath Mahapatra
All India Institute of Medical Sciences, new Delhi
Outcome results
None listed