Treatment With Balanced Crystalloid Solutions in the Early Phase of Acute Pancreatitis
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 276
- Locations
- 1
- Primary Endpoint
- Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Balanced crystalloid solution
Balanced crystalloid solution - Plasmalyte.
Intervention: Balanced crystalloid solution (Drug)
Normal saline
0.9% sodium chloride solution.
Intervention: Normal saline (Drug)
Outcomes
Primary Outcomes
Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS)
Time Frame: 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 Outcomes
- Mortality(30 days)
- Number of participants with organ failure (transitory and persistent)(30 days)
- Number of participants with local complications(30 days)
- Number od participants with systemic complications(30 days)
- Number of participants with infected pancreatic necrosis(30 days)
- Number of participants needing endoscopic / percutaneous / surgical interventions(30 days)
- Length of hospital stay(30 days)
Investigators
Goran Poropat
Asst. Prof.
University Hospital Rijeka