Acute Pancreatitis, Complication, Mortality Rate, Organ Failure, Multiple
Conditions
Keywords
Acute pancreatitis, Indomethacin, Prognosis, Organ dysfunction
Brief summary
Acute pancreatitis (AP) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. The production and release of inflammatory factors is generally considered as the key factor of pathogenesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly applied agents for inflammatory diseases. A series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ERCP), but high-quality evidence is still lacking in the field of effectiveness of NSAIDs to treat, rather than prevent, other types of AP. Majority of animal experiments showed that NSAIDs had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. Randomized controlled trials are eagerly awaited to elucidate its effects on AP.
Interventions
DRUGIndomethacin SR
Indomethacin SR 50mg given q12h from admission day 1 to day 7
DRUGPlacebos
Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* All patients ages 18-80 years with a diagnosis of AP based on at least 2 of the following criteria: * Abdominal pain characteristic of AP * Serum amylase and/or lipase ≥ 3 times the upper limit of normal * Characteristic findings of AP on abdominal CT scan will be screened for study enrollment.
Exclusion criteria
* Onset time \>24 hours * Presence of renal dysfunction (serum creatinine \> 1.5 \*normal upper limit) * Severe liver dysfunction * Active peptic ulcer disease or GI bleeding * Pregnancy or breast-feeding * Hypersensitivity to NSAIDs * New-onset, exacerbation or uncontrolled hypertension * Presence of serious cardiovascular events, including severe heart failure, myocardial infarction (MI) and stroke * Mental disability * Malignancy-associated acute pancreatitis * Post-ERCP pancreatitis * Informed consent not signed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence rate of organ dysfunction caused by acute pancreatitis | 1 week | Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurence rate of pancreatic necrosis | 1 month | Accumulation of the key local complication of acute pancreatitis |
| Incidence rate of ICU admission | 1 month | Evaluation of critical severe acute pancreatitis |
| Mortality | 1 month | The number of deaths during a particular period of time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization cost | 1 month | Expense of acute pancreatitis |
Countries
China
Contacts
Primary ContactDong Wu, M.D.
Outcome results
None listed