CC BY-NC-ND 4.0 · Endosc Int Open 2022; 10(07): E933-E939
DOI: 10.1055/a-1834-6568
Original article

Efficacy of aggressive hydration with normal saline versus lactated Ringer’s solution for the prevention of post-ERCP pancreatitis in high-risk patients: a randomized controlled trial

Rupal Patel
1   University of South Florida College of Medicine, Division of Digestive Disease and Nutrition, Department of Internal Medicine, Tampa, Florida, United States
,
Carlos Bertran-Rodriguez
2   University of South Florida College of Medicine, Department of Internal Medicine, Tampa, Florida, United States
,
Ambuj Kumar
3   University of South Florida College of Medicine, Office of Research, Department of Internal Medicine, Tampa, Florida, United States
,
Patrick Brady
1   University of South Florida College of Medicine, Division of Digestive Disease and Nutrition, Department of Internal Medicine, Tampa, Florida, United States
,
Rene Gomez-Esquivel
1   University of South Florida College of Medicine, Division of Digestive Disease and Nutrition, Department of Internal Medicine, Tampa, Florida, United States
,
Kinesh Changela
1   University of South Florida College of Medicine, Division of Digestive Disease and Nutrition, Department of Internal Medicine, Tampa, Florida, United States
,
Negar Niknam
1   University of South Florida College of Medicine, Division of Digestive Disease and Nutrition, Department of Internal Medicine, Tampa, Florida, United States
,
Pushpak Taunk
1   University of South Florida College of Medicine, Division of Digestive Disease and Nutrition, Department of Internal Medicine, Tampa, Florida, United States
› Author Affiliations
TRIAL REGISTRATION: Randomized blinded controlled trial at http://www.clinicaltrials.gov/
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Abstract

Background and study aims Post-ERCP pancreatitis (PEP) is a common adverse event in high-risk patients. Current intervention known to reduce the incidence and severity of PEP include pancreatic duct stent placement, nonsteroidal anti-inflammatory drugs per rectum, and intravenous (IV) fluids. We compared aggressive normal saline (NS) vs aggressive lactated Ringer’s (LR) infusion for the prevention of PEP in high-risk patients undergoing ERCP.

Patients and methods Patients were randomized to receive either an aggressive infusion of NS or LR. The infusion was started at a rate of 3 mL/kg/hr and continued throughout the ERCP procedure. A 20 mL/kg bolus was given at the end of the procedure, then continued at a rate of 3 mL/kg/hr.

Results A total of 136 patients were included in our analysis. The incidence of PEP was 4 % (3/72 patients) in the LR group versus 11 % (7/64 patients) in the NS group resulting in a relative risk (RR) of 0.38 (95 % confidence interval [CI] 0.10 to 1.42; P = 0.19). The relative risk reduction (RRR) was 0.62 (95 % CI –0.41 to 0.90) along with an absolute risk reduction (ARR) of 0.07 (95 % CI –0.025 to 0.17) and an number needed to treat of 15 (95 % CI –41 to 6).

Conclusions To our knowledge, this is the first study comparing aggressive IV NS to aggressive IV LR in high-risk patients. The incidence of PEP was lower in the group receiving an aggressive LR infusion (4 %) compared to NS infusion (11 %). However, the difference was not statistically significant likely due to poor accrual thereby impacting the power of the study.



Publication History

Received: 15 July 2021

Accepted after revision: 25 April 2022

Accepted Manuscript online:
25 April 2022

Article published online:
15 July 2022

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