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NCT Number: NCT02897206

Imipenem Prophylaxis 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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Infections Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Rijeka

Rijeka, 51000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imipenem

Drug

A wide-spectre antibiotic from the carbapenem group

Other names: Imipenem-cilastatin

Placebo

Drug

An imipenem-matching placebo

Primary outcomes

  1. Infectious complications

    Time frame: 30 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Rijeka

Other

Collaborators

  • University of Rijeka

Registry information

Official study title

Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis

Acronym: IMPROWE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2016
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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