Imipenem Prophylaxis in Patients With Acute Pancreatitis (IMPROWE)

Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis

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.

Study Overview

• Status: Completed
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Drug: Imipenem; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 4

Contacts and Locations

Study Locations

• Croatia
  • Rijeka, Croatia, 51000
    • University Hospital Rijeka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital Rijeka
• Collaborators: University of Rijeka
• Investigators: Principal Investigator: Davor Štimac, MD, PhD, Department of Gastroenterology, University Hospital Rijeka

Publications and helpful links

General Publications

• Poropat G, Radovan A, Peric M, Mikolasevic I, Giljaca V, Hauser G, Milic S, Stimac D. Prevention of Infectious Complications in Acute Pancreatitis: Results of a Single-Center, Randomized, Controlled Trial. Pancreas. 2019 Sep;48(8):1056-1060. doi: 10.1097/MPA.0000000000001368.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 20, 2015
• First Submitted That Met QC Criteria: September 10, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 18, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Infection; Antibiotic prophylaxis; Acute pancreatitis; Organ failure; Imipenem-cilastatin; Infected pancreatic necrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Protease Inhibitors; Anti-Bacterial Agents; Imipenem; Cilastatin; Cilastatin, Imipenem Drug Combination
• Other Study ID Numbers: 13.06.1.2.30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No