Imipenem Prophylaxis in Patients With Acute Pancreatitis

Study Overview
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Brief Summary
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This is a prospective, single-center, randomized, placebo-controlled, double-blind clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with predicted severe acute pancreatitis. All patients with first attack of acute pancreatitis, an onset of disease less than 72h before admission, and an APACHE II score ≥ 8 calculated within the first 24h from admission will be enrolled.

Official Title
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Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Drug: Imipenem
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of acute pancreatitis defined by the Revised 2012 Atlanta Criteria first manifestation of acute pancreatitis regardless of etiology APACHE II ≥ 8 calculated within the first 24 hours of admission onset of symptoms < 72 hours before admission Exclusion Criteria: age < 18 years pregnant and breastfeeding women active and documented infection at admission concomitant antibiotic treatment or antibiotic treatment present within 72 hours before enrollment acute pancreatitis diagnosed at surgery active malignancy known immune deficiency patients with chronic pancreatitis patients unwilling to participate in the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imipenem group<br>Imipenem 3 x 500 mg i.v. daily ideally for 10 days (minimum 7 days, maximum 21 days) | Drug: Imipenem<br>* A wide-spectre antibiotic from the carbapenem group<br>* Other names: Imipenem-cilastatin;|
| Placebo Comparator: Placebo group<br>Identical placebo administered in identical dosage, timing and duration. | Drug: Placebo<br>* An imipenem-matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complications |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30 days | 
| Number of patients with Systemic Inflammatory Response Syndrome (SIRS) | SIRS was defined as presence of at least two following parameters for a continuous period of ≥ 48 hours: body temperature >38°C or <36°C; heart rate >90 beats per minute; hyperventilation with a respiratory rate >20 breath per minute or a PaCO2 < 32 mmHg; and white blood cell count >12000/mm3 or <4000/mm3. | 30 days | 
| Local complications |  | 30 days | 
| Systemic complications |  | 30 days | 
| Number of patients with persistent and transitory organ failure (cardiovascular, respiratory, renal) | Marshall organ dysfunction scoring system (MODS) was used to define organ failure in the case of cardiovascular, renal and respiratory system function. | 30 days | 
| Surgical interventions | The investigators will register the number of patients requiring surgical interventions for acute pancreatitis. | 30 days | 
| Serious adverse events |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute pancreatitis, Antibiotic prophylaxis, Imipenem-cilastatin, Infected pancreatic necrosis, Infection, Organ failure