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Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis (NCT02897206)

University of Rijeka
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.
  • Drug: Imipenem
    A wide-spectre antibiotic from the carbapenem group
    • Imipenem-cilastatin
  • Drug: Placebo
    An imipenem-matching placebo
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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

    1 locations

    Croatia (1)
    • University Hospital Rijeka
      Not specified
      Rijeka, Croatia, 51000
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    30 September, 2014
    Updated:
    17 June, 2017
    Participants:
    98
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