Imipenem Prophylaxis in Patients With Acute Pancreatitis (IMPROWE)
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|ClinicalTrials.gov Identifier: NCT02897206|
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Pancreatitis||Drug: Imipenem Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Imipenem group
Imipenem 3 x 500 mg i.v. daily ideally for 10 days (minimum 7 days, maximum 21 days)
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.
An imipenem-matching placebo
- Infectious complications [ Time Frame: 30 days ]
- Mortality [ Time Frame: 30 days ]
- 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.
- Local complications [ Time Frame: 30 days ]
- Systemic complications [ Time Frame: 30 days ]
- 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.
- Surgical interventions [ Time Frame: 30 days ]The investigators will register the number of patients requiring surgical interventions for acute pancreatitis.
- Serious adverse events [ Time Frame: 30 days ]
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
|University Hospital Rijeka|
|Rijeka, Croatia, 51000|
|Principal Investigator:||Davor Stimac, MD, PhD||Department of Gastroenterology, University Hospital Rijeka|