Balanced Crystalloid Solutions for Acute Pancreatitis
- Conditions
- Acute Pancreatitis
- Interventions
- Drug: Balanced crystalloid solutionDrug: Normal saline
- Registration Number
- NCT04688645
- Lead Sponsor
- University Hospital Rijeka
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 276
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Balanced crystalloid solution Balanced crystalloid solution Balanced crystalloid solution - Plasmalyte. Normal saline Normal saline 0.9% sodium chloride solution.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 necrosisNumber od participants with systemic complications 30 days Worsening of existing concomitant diseases
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.
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.
Trial Locations
- Locations (1)
University Hospital Rijeka
🇭🇷Rijeka, Croatia