NCT04688645

Balanced Crystalloid Solutions for Acute Pancreatitis

Treatment With Balanced Crystalloid Solutions in the Early Phase of Acute Pancreatitis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: University Hospital Rijeka · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pancreatitis

Interventions

Type	Name	Description
DRUG	Balanced crystalloid solution	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.
DRUG	Normal 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.

Timeline

• Start date: 2020-05-01
• Primary completion: 2022-12-01
• Completion: 2023-02-01
• First posted: 2020-12-30
• Last updated: 2020-12-30

Locations

1 site across 1 country: Croatia