Acute Pancreatitis
Conditions
Keywords
Acute pancreatitis, Antibiotic prophylaxis, Imipenem-cilastatin, Infected pancreatic necrosis, Infection, Organ failure
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.
Interventions
DRUGImipenem
A wide-spectre antibiotic from the carbapenem group
DRUGPlacebo
An imipenem-matching placebo
Sponsors
University of Rijeka
University Hospital Rijeka
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infectious complications | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Systemic Inflammatory Response Syndrome (SIRS) | 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 | 30 days | — |
| Systemic complications | 30 days | — |
| Mortality | 30 days | — |
| Surgical interventions | 30 days | The investigators will register the number of patients requiring surgical interventions for acute pancreatitis. |
| Serious adverse events | 30 days | — |
| Number of patients with persistent and transitory organ failure (cardiovascular, respiratory, renal) | 30 days | Marshall organ dysfunction scoring system (MODS) was used to define organ failure in the case of cardiovascular, renal and respiratory system function. |
Countries
Croatia
Outcome results
None listed