Imipenem Prophylaxis in Patients With Acute Pancreatitis

Phase 4

Completed

• Conditions: Acute Pancreatitis
• Interventions: Drug: Placebo; Drug: Imipenem

• Registration Number: NCT02897206
• Lead Sponsor: University Hospital Rijeka

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-12-20
• Study First Submitted QC: 2016-09-10
• Study First Posted: 2016-09-13
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-18
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Identical placebo administered in identical dosage, timing and duration.
Imipenem group	Imipenem	Imipenem 3 x 500 mg i.v. daily ideally for 10 days (minimum 7 days, maximum 21 days)

Primary Outcome Measures

Name	Time	Method
Infectious complications	30 days

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days
Number of patients with Systemic Inflammatory Response Syndrome (SIRS)	30 days	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.
Surgical interventions	30 days	The investigators will register the number of patients requiring surgical interventions for acute pancreatitis.
Serious adverse events	30 days
Local complications	30 days
Systemic complications	30 days
Number of patients with persistent and transitory organ failure (cardiovascular, respiratory, renal)	30 days	Marshall organ dysfunction scoring system (MODS) was used to define organ failure in the case of cardiovascular, renal and respiratory system function.

Trial Locations

Locations (1)

University Hospital Rijeka; 🇭🇷 Rijeka, Croatia