IMPROWE: Imipenem Prophylaxis in Patients With Acute Pancreatitis

Sponsor

University Hospital Rijeka (Other)

Overall Status

Completed

CT.gov ID

NCT02897206

Collaborator

University of Rijeka (Other)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pancreatitis	Drug: Imipenem Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Imipenem group

Imipenem 3 x 500 mg i.v. daily ideally for 10 days (minimum 7 days, maximum 21 days)

Drug: Imipenem

A wide-spectre antibiotic from the carbapenem group

Other Names:

Imipenem-cilastatin

Placebo Comparator: Placebo group

Identical placebo administered in identical dosage, timing and duration.

Drug: Placebo

An imipenem-matching placebo

Outcome Measures

Primary Outcome Measures

Infectious complications [30 days]

Secondary Outcome Measures

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.
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.
Surgical interventions [30 days]
The investigators will register the number of patients requiring surgical interventions for acute pancreatitis.
Serious adverse events [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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