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Imipenem Prophylaxis in Patients With Acute Pancreatitis (IMPROWE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02897206
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
University of Rijeka
Information provided by (Responsible Party):
Goran Poropat, 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.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Drug: Imipenem Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : October 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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 Name: Imipenem-cilastatin

Placebo Comparator: Placebo group
Identical placebo administered in identical dosage, timing and duration.
Drug: Placebo
An imipenem-matching placebo




Primary Outcome Measures :
  1. Infectious complications [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
  2. Number of patients with Systemic Inflammatory Response Syndrome (SIRS) [ Time Frame: 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.

  3. Local complications [ Time Frame: 30 days ]
  4. Systemic complications [ Time Frame: 30 days ]
  5. Number of patients with persistent and transitory organ failure (cardiovascular, respiratory, renal) [ Time Frame: 30 days ]
    Marshall organ dysfunction scoring system (MODS) was used to define organ failure in the case of cardiovascular, renal and respiratory system function.

  6. Surgical interventions [ Time Frame: 30 days ]
    The investigators will register the number of patients requiring surgical interventions for acute pancreatitis.

  7. Serious adverse events [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897206


Locations
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Croatia
University Hospital Rijeka
Rijeka, Croatia, 51000
Sponsors and Collaborators
University Hospital Rijeka
University of Rijeka
Investigators
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Principal Investigator: Davor Stimac, MD, PhD Department of Gastroenterology, University Hospital Rijeka
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Goran Poropat, Postdoctoral Researcher, University Hospital Rijeka
ClinicalTrials.gov Identifier: NCT02897206    
Other Study ID Numbers: 13.06.1.2.30
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Goran Poropat, University Hospital Rijeka:
Acute pancreatitis
Antibiotic prophylaxis
Imipenem-cilastatin
Infected pancreatic necrosis
Infection
Organ failure
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Imipenem
Cilastatin, Imipenem Drug Combination
Cilastatin
Anti-Bacterial Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action