Acute Pancreatitis
Conditions
Brief summary
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.
Interventions
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.
DRUGNormal saline
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.
Sponsors
University of Rijeka
University Hospital Rijeka
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- patients diagnosed with acute pancreatitis based on the revised Atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis
Exclusion criteria
* chronic pancreatitis * liver cirrhosis (Child-Pugh B and C) * chronic hearth failure (NYHA\>II) * acute coronary syndrome * cardiovascular intervention within 60 days before randomization * chronic obstructive pulmonary disease dependent of home oxygenator or acute exacerbation of chronic obstructive pulmonary disease * chronic kidney disease (eGFR \<30 ml/min/1.73 m2) * concomitant biliary infection (cholecystitis, cholangitis) * severe autoimmune disease * chronic active infection (TBC, AIDS) * metastatic malignant disease * primary pancreatic neoplasm * patients transferred from other hospitals * pregnancy and ongoing breastfeeding * not willing to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS) | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | Number of death cases |
| Number of participants with organ failure (transitory and persistent) | 30 days | Organ failure defined according to the modified Marshall criteria |
| Number of participants with local complications | 30 days | Local complications including: * acute peripancreatic fluid collection * acute necrotic collection * pseudocyst * walled-off necrosis |
| Number od participants with systemic complications | 30 days | Worsening of existing concomitant diseases |
| Number of participants needing endoscopic / percutaneous / surgical interventions | 30 days | In cases when presence of local infection or local complications (i.e. collection compressing surrounding organs and causing symptoms) requires an intervention |
| Length of hospital stay | 30 days | Number of days in hospital, from admission to discharge or death. |
| Number of participants with infected pancreatic necrosis | 30 days | 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. |
Countries
Croatia
Contacts
Primary ContactGoran Poropat, MD, PhD
Backup ContactAnja Radovan, MD
Outcome results
None listed