search
Back to results

Imipenem Prophylaxis in Patients With Acute Pancreatitis (IMPROWE)

Primary Purpose

Acute Pancreatitis

Status
Completed
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
Imipenem
Placebo
Sponsored by
University Hospital Rijeka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pancreatitis focused on measuring Acute pancreatitis, Antibiotic prophylaxis, Imipenem-cilastatin, Infected pancreatic necrosis, Infection, Organ failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Rijeka

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Imipenem group

Placebo group

Arm Description

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

Identical placebo administered in identical dosage, timing and duration.

Outcomes

Primary Outcome Measures

Infectious complications

Secondary Outcome Measures

Mortality
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.
Local complications
Systemic complications
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.
Surgical interventions
The investigators will register the number of patients requiring surgical interventions for acute pancreatitis.
Serious adverse events

Full Information

First Posted
December 20, 2015
Last Updated
June 18, 2017
Sponsor
University Hospital Rijeka
Collaborators
University of Rijeka
search

1. Study Identification

Unique Protocol Identification Number
NCT02897206
Brief Title
Imipenem Prophylaxis in Patients With Acute Pancreatitis
Acronym
IMPROWE
Official Title
Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Rijeka
Collaborators
University of Rijeka

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
Acute pancreatitis, Antibiotic prophylaxis, Imipenem-cilastatin, Infected pancreatic necrosis, Infection, Organ failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imipenem group
Arm Type
Experimental
Arm Description
Imipenem 3 x 500 mg i.v. daily ideally for 10 days (minimum 7 days, maximum 21 days)
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Identical placebo administered in identical dosage, timing and duration.
Intervention Type
Drug
Intervention Name(s)
Imipenem
Other Intervention Name(s)
Imipenem-cilastatin
Intervention Description
A wide-spectre antibiotic from the carbapenem group
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
An imipenem-matching placebo
Primary Outcome Measure Information:
Title
Infectious complications
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
30 days
Title
Number of patients with Systemic Inflammatory Response Syndrome (SIRS)
Description
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.
Time Frame
30 days
Title
Local complications
Time Frame
30 days
Title
Systemic complications
Time Frame
30 days
Title
Number of patients with persistent and transitory organ failure (cardiovascular, respiratory, renal)
Description
Marshall organ dysfunction scoring system (MODS) was used to define organ failure in the case of cardiovascular, renal and respiratory system function.
Time Frame
30 days
Title
Surgical interventions
Description
The investigators will register the number of patients requiring surgical interventions for acute pancreatitis.
Time Frame
30 days
Title
Serious adverse events
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davor Stimac, MD, PhD
Organizational Affiliation
Department of Gastroenterology, University Hospital Rijeka
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31404018
Citation
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.
Results Reference
derived

Learn more about this trial

Imipenem Prophylaxis in Patients With Acute Pancreatitis

We'll reach out to this number within 24 hrs