Imipenem Prophylaxis in Patients With Acute Pancreatitis

Acute Pancreatitis Clinical Trial

— IMPROWE  

Official title:

Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897206
• Other study ID #: 13.06.1.2.30
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2015
• Last updated: June 18, 2017
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: University Hospital Rijeka
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Drug:
• Imipenem
A wide-spectre antibiotic from the carbapenem group
• Placebo
An imipenem-matching placebo

Locations

Country	Name	City	State
Croatia	University Hospital Rijeka	Rijeka

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Rijeka	University of Rijeka

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious complications		30 days
Secondary	Mortality		30 days
Secondary	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.	30 days
Secondary	Local complications		30 days
Secondary	Systemic complications		30 days
Secondary	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.	30 days
Secondary	Surgical interventions	The investigators will register the number of patients requiring surgical interventions for acute pancreatitis.	30 days
Secondary	Serious adverse events		30 days