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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
98
University Hospital Rijeka
Rijeka, Croatia
Infectious complications
Time frame: 30 days
Mortality
Time frame: 30 days
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.
Time frame: 30 days
Local complications
Time frame: 30 days
Systemic complications
Time frame: 30 days
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.
Time frame: 30 days
Surgical interventions
The investigators will register the number of patients requiring surgical interventions for acute pancreatitis.
Time frame: 30 days
Serious adverse events
Time frame: 30 days
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