Aggressive Intravenous Hydration With Lactated Ringer's Solution for Prevention of Post-ESWL Pancreatitis

NCT05772234 | Completed DMC

• 1 other identifier: HYPER20221204
• Study Type: interventional
• Target: 1,066
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to clarify whether aggressive intravenous hydration with lactated Ringer's solution could reduce the incidence of post-ESWL pancreatitis in patients with chronic pancreatitis.

Conditions

Pancreatitis, Chronic; Pancreatic Duct Stone

Keywords

pancreatic extracorporeal shock wave lithotripsy; post-ESWL pancreatits; intravenous hydration; lactated Ringer's solution

Outcome Measures

Primary Outcomes (1)

• Incidence of post-ESWL pancreatitis

  Post-ESWL pancreatitis is defined according to the 2012 Atlanta criteria. A diagnosis of post-ESWL pancreatitis is made if two of three of the following criteria are met: pain consistent with pancreatitis; amylase or lipase of at least three times the upper normal limit within 24 h of the procedure; or characteristic findings on imaging.

  24 hours

Secondary Outcomes (3)

• Severity of pancreatitis

  1 month

• Incidence of other post-ESWL complications

  24 hours

• Incidence of fluid overload

  24 hours

Study Arms (2)

Aggressive hydration group

EXPERIMENTAL

Periprocedural hydration with intravenous 20 mL/kg lactated Ringer's solution within 60 min from the start of ESWL (first shockwave delivered), directly followed by 3 mL/kg per h for 8 h.

Drug: Lactated ringers solution

Restricted hydration group

ACTIVE COMPARATOR

Periprocedural hydration with normal saline (maximum of 1.5mL/kg per h or 3L per 24h).

Drug: normal saline

Interventions

Lactated ringers solution DRUG

Intravenous 20 mL/kg Ringer's lactate solution within 60 min from the start of ESWL, directly followed by 3 mL/kg per h for 8 h.

Aggressive hydration group

normal saline DRUG

Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h).

Restricted hydration group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with chronic pancreatitis aged between18 and 85 years who were eligible for treatment with ESWL for pancreatic stones were eligible for enrolment.

You may not qualify if:

• Patients readmitted to the hospital for ESWL during the study period.
• Acute pancreatitis in the last 3 days.
• Signs of congestive heart failure, such as pitting edema or a New York Heart Association classification greater than class I heart failure. For patients ≥ 70 years old, brain natriuretic peptide (BNP) and cardiac ultrasound would be performed before ESWL. Patients with BNP\>100pg/ml or Ejection Fraction value\<50% should be excluded.
• Respiratory insufficiency (pO2 \< 60 mmHg or saturation \< 90% despite FiO2 of 30% or requiring mechanical ventilation). For patients ≥ 70 years old, pulmonary function tests would be performed before ESWL. Patients with Forced Expiratory Volume in the first second (FEV1) \<70% are excluded.
• Severe liver disease (cirrhosis, liver abscess).
• Patients receiving more than 1.5 mL/kg/h or 3 L/24 h of intravenous fluids in the 24 h before ESWL.
• Hypotension (systolic blood pressure \<90 mmHg or mean arterial pressure \<70 mmHg).
• Hypo- or hypernatremia (serum Na+ levels \< 130 or \> 150 mmol/L).
• Pregnancy.
• Unwilling or unable to provide consent.

Sponsors & Collaborators

• Changhai Hospital: lead
• Ruijin Hospital: collaborator
• LanZhou University: collaborator
• First People's Hospital of Hangzhou: collaborator
• The Second Affiliated Hospital of Baotou Medical College: collaborator
• Shanghai Pudong New Area Gongli Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Affiliated Hospital of Yunnan University: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (11)

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• Buxbaum JL, Freeman M, Amateau SK, Chalhoub JM, Coelho-Prabhu N, Desai M, Elhanafi SE, Forbes N, Fujii-Lau LL, Kohli DR, Kwon RS, Machicado JD, Marya NB, Pawa S, Ruan WH, Sheth SG, Thiruvengadam NR, Thosani NC, Qumseya BJ; (ASGE Standards of Practice Committee Chair). American Society for Gastrointestinal Endoscopy guideline on post-ERCP pancreatitis prevention strategies: summary and recommendations. Gastrointest Endosc. 2023 Feb;97(2):153-162. doi: 10.1016/j.gie.2022.10.005. Epub 2022 Dec 12. No abstract available.

  PMID: 36517310 BACKGROUND

• Skolarikos A, Alivizatos G, de la Rosette J. Extracorporeal shock wave lithotripsy 25 years later: complications and their prevention. Eur Urol. 2006 Nov;50(5):981-90; discussion 990. doi: 10.1016/j.eururo.2006.01.045. Epub 2006 Feb 7.

  PMID: 16481097 BACKGROUND

• Li BR, Liao Z, Du TT, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Hao JF, Jiang YY, Hu LH, Li ZS. Risk factors for complications of pancreatic extracorporeal shock wave lithotripsy. Endoscopy. 2014 Dec;46(12):1092-100. doi: 10.1055/s-0034-1377753. Epub 2014 Sep 24.

  PMID: 25251205 BACKGROUND

• Tandan M, Nageshwar Reddy D, Talukdar R, Vinod K, Kiran SVVS, Santosh D, Gupta R, Ramchandani M, Lakhtakia S, Rakesh K, Manohar Reddy P, Basha J, Nabi Z, Jagtap N, Rao GV. ESWL for large pancreatic calculi: Report of over 5000 patients. Pancreatology. 2019 Oct;19(7):916-921. doi: 10.1016/j.pan.2019.08.001. Epub 2019 Aug 2.

  PMID: 31447280 BACKGROUND

• Qian YY, Ru N, Chen H, Zou WB, Wu H, Pan J, Li B, Xin L, Guo JY, Tang XY, Hu LH, Jin ZD, Wang D, Du YQ, Wang LW, Li ZS, Liao Z. Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):238-244. doi: 10.1016/S2468-1253(21)00434-9. Epub 2022 Jan 25.

  PMID: 35085482 BACKGROUND

• Choi JH, Kim HJ, Lee BU, Kim TH, Song IH. Vigorous Periprocedural Hydration With Lactated Ringer's Solution Reduces the Risk of Pancreatitis After Retrograde Cholangiopancreatography in Hospitalized Patients. Clin Gastroenterol Hepatol. 2017 Jan;15(1):86-92.e1. doi: 10.1016/j.cgh.2016.06.007. Epub 2016 Jun 14.

  PMID: 27311618 BACKGROUND

• Park CH, Paik WH, Park ET, Shim CS, Lee TY, Kang C, Noh MH, Yi SY, Lee JK, Hyun JJ, Lee JK. Aggressive intravenous hydration with lactated Ringer's solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial. Endoscopy. 2018 Apr;50(4):378-385. doi: 10.1055/s-0043-122386. Epub 2017 Dec 13.

  PMID: 29237204 BACKGROUND

• Sperna Weiland CJ, Smeets XJNM, Kievit W, Verdonk RC, Poen AC, Bhalla A, Venneman NG, Witteman BJM, da Costa DW, van Eijck BC, Schwartz MP, Romkens TEH, Vrolijk JM, Hadithi M, Voorburg AMCJ, Baak LC, Thijs WJ, van Wanrooij RL, Tan ACITL, Seerden TCJ, Keulemans YCA, de Wijkerslooth TR, van de Vrie W, van der Schaar P, van Dijk SM, Hallensleben NDL, Sperna Weiland RL, Timmerhuis HC, Umans DS, van Hooft JE, van Goor H, van Santvoort HC, Besselink MG, Bruno MJ, Fockens P, Drenth JPH, van Geenen EJM; Dutch Pancreatitis Study Group. Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2021 May;6(5):350-358. doi: 10.1016/S2468-1253(21)00057-1. Epub 2021 Mar 19.

  PMID: 33740415 BACKGROUND

• Wu BU, Hwang JQ, Gardner TH, Repas K, Delee R, Yu S, Smith B, Banks PA, Conwell DL. Lactated Ringer's solution reduces systemic inflammation compared with saline in patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):710-717.e1. doi: 10.1016/j.cgh.2011.04.026. Epub 2011 May 12.

  PMID: 21645639 BACKGROUND

• Radadiya D, Devani K, Arora S, Charilaou P, Brahmbhatt B, Young M, Reddy C. Peri-Procedural Aggressive Hydration for Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis Prophylaxsis: Meta-analysis of Randomized Controlled Trials. Pancreatology. 2019 Sep;19(6):819-827. doi: 10.1016/j.pan.2019.07.046. Epub 2019 Jul 30.

  PMID: 31383573 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Ringer's Lactate; Saline Solution

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Lianghao Hu, M.D.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 16, 2023
• Study Start: November 17, 2023
• Primary Completion: March 18, 2025
• Study Completion: March 23, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)