Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. The control group will receive normal saline at the same rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
276
Balanced crystalloid solution (Plasmalyte) given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.
0.9% sodium chloride solution given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.
University Hospital Rijeka
Rijeka, Croatia
RECRUITINGNumber of Participants with New Onset Systemic inflammatory response syndrome (SIRS)
Body temperature less than 36 °C (96.8 °F) or greater than 38 °C (100.4 °F); heart rate greater than 90 beats per minute; tachypnea (high respiratory rate), with greater than 20 breaths per minute or, an arterial partial pressure of carbon dioxide less than 4.3 kilopascals (32 mmHg); white blood cell count less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L) or the presence of greater than 10% immature neutrophils.
Time frame: 30 days
Mortality
Number of death cases
Time frame: 30 days
Number of participants with organ failure (transitory and persistent)
Organ failure defined according to the modified Marshall criteria
Time frame: 30 days
Number of participants with local complications
Local complications including: * acute peripancreatic fluid collection * acute necrotic collection * pseudocyst * walled-off necrosis
Time frame: 30 days
Number od participants with systemic complications
Worsening of existing concomitant diseases
Time frame: 30 days
Number of participants with infected pancreatic necrosis
Defined by positive cultures from fine-needle aspiration of necrotic tissue or by the combination of clinical deterioration with clinical signs of infection and presence of gas within the necrotic tissue on imaging in cases of culture-negative, but highly suspicious cases.
Time frame: 30 days
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Number of participants needing endoscopic / percutaneous / surgical interventions
In cases when presence of local infection or local complications (i.e. collection compressing surrounding organs and causing symptoms) requires an intervention
Time frame: 30 days
Length of hospital stay
Number of days in hospital, from admission to discharge or death.
Time frame: 30 days