Balanced Crystalloid Solutions for Acute Pancreatitis

University Hospital Rijeka

Status and phase: Unknown; Phase 4

Conditions: Acute Pancreatitis

Treatments: Drug: Normal saline; Drug: Balanced crystalloid solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04688645

uniri-biomed-18-154

Details and patient eligibility

About

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.

Enrollment: 276 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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276 participants in 2 patient groups

Balanced crystalloid solution

Experimental group

Description:

Balanced crystalloid solution - Plasmalyte.

Treatment:

Drug: Balanced crystalloid solution

Normal saline

Active Comparator group

Description:

0.9% sodium chloride solution.

Treatment:

Drug: Normal saline