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Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP Pancreatitis

NCT05832047 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 844

Last updated 2025-02-06

No results posted yet for this study

Summary

In the existing Aggressive hydration comparison study related to the prevention of post-ERCP pancreatitis (PEP), research bias may occur due to the lack of blinding between fluids, so in this study, the investigators will conduct a multicenter randomized comparative study in which the comparative fluids are double-blinded to observe differences between fluids in the preventive effect of pancreatitis that occurs after ERCP (endoscopic retrograde cholangiopancreatography).

A total of 844 patients scheduled for ERCP will be enrolled in this clinical trial and randomly assigned to the lactated Ringer's solution or to the Plasma solution in a 1:1 ratio. Eligible patients will receive study drug or control drug for up to 24 hours before and after ERCP implementation.

In previous comparative studies related to PEP prevention, research bias may have been introduced because of insufficient blinding of the treatment strategies, as well as instances where the evaluating investigator did not perform blinding. We are therefore conducting a multicenter, randomized comparative study double-blinded as to the two types of fluid (lactated Ringer's solution or plasma solution), and in which the endoscopists, outcome assessors and patients are blinded to the randomization allocation.

Conditions

  • Pancreatic Disease

Interventions

DRUG

Plasma solution (4-hour aggressive hydration)

Aggressive hydration : 10 mL/kg injection within 30\~90min before procedure, 3 mL/kg/hr fluid injection during procedure, 10 mL/kg injection within 30\~60min after procedure, fluid, injection at 3 mL/kg/hr for 4 hours.

DRUG

Lactated Ringer solution (4-hour aggressive hydration)

Aggressive hydration : 10 mL/kg injection within 30\~90min before procedure, 3 mL/kg/hr fluid injection during procedure, 10 mL/kg injection within 30\~60min after procedure, fluid, injection at 3 mL/kg/hr for 4 hours.

DRUG

8-hour aggressive hydration

If patients experienced postprocedural abdominal pain Numerical Rating Scale (NRS score\>3) or a worsening of abdominal pain compared with the pain before ERCP, the administration of study fluid continues until 8 hours (3 mL/kg/hr ) regardless of the results of serum amylase/lipase within 4 hours after ERCP because serum amylase/lipase within 4 hours after ERCP may have a result approximately 1-2 hours (5 hours-6 hours after ERCP) after blood sampling

Sponsors & Collaborators

  • HK inno.N Corporation

    collaborator INDUSTRY

  • Do Hyun Park

    lead OTHER

Principal Investigators

  • Do Hyun Park, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-19
Primary Completion
2024-07-25
Completion
2025-01-20

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832047 on ClinicalTrials.gov