Imipenem Prophylaxis in Patients With Acute Pancreatitis (IMPROWE)

University Hospital Rijeka

Status and phase

Completed

Phase 4

Conditions

Acute Pancreatitis

Treatments

Drug: Imipenem

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02897206

13.06.1.2.30

Details and patient eligibility

About

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.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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