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

PHASE4CompletedINTERVENTIONAL
Enrollment

844

Participants

Timeline

Start Date

June 19, 2023

Primary Completion Date

July 25, 2024

Study Completion Date

January 20, 2025

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

Trial Locations (3)

Unknown

Asan Medical Center, Seoul

Samsung Seoul Hopital, Seoul

Seoul National University Hospital, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

HK inno.N Corporation

INDUSTRY

lead

Do Hyun Park

OTHER

NCT05832047 - Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP Pancreatitis | Biotech Hunter | Biotech Hunter