Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis

NCT02821546 | Completed Phase 3

• 1 other identifier: Si416/2014
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

Aggressive hydration with lactated Ringer's solution (LRS) has been shown in a preliminary research to reduce the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. This randomized, controlled trial was designed to assess the effect of peri-procedural aggressive intravenous hydration with LRS on the incidence of post ERCP pancreatitis.

Conditions

Pancreatitis

Outcome Measures

Primary Outcomes (1)

• post ERCP pancreatitis

  Post ERCP pancreatitis is defined as hyperamylasemia (amylase \>3 times the upper limit of normal \[300 U/L\]) and pancreatic pain (epigastric abdominal pain radiating to the back scored by patient as development of or increase of pain ≥3 on a 0-10 visual analogue pain scale and persisting for ≥24 hours after ERCP). In those who had pain before the procedure, pancreatic pain is defined as an increase of ≥3 on the 0-10 visual analogue scale.

  24 hours

Secondary Outcomes (1)

• severity of post ERCP pancreatitis

  24 hours

Study Arms (2)

standard hydration

PLACEBO COMPARATOR

Patients underwent first-time ERCP to receive standard fluid hydration with Lactated Ringer's solution at a rate calculated by the Holliday-Segar method given peri-procedurally starting 2 hours prior to procedure, and continued during and after procedure to complete 24 hours.

Drug: Lactated Ringer's solution

aggressive hydration

ACTIVE COMPARATOR

Patients underwent first-time ERCP to receive aggressive fluid hydration with Lactated Ringer's solution at a rate of 150 ml/hr starting 2 hours prior to procedure, and continued during and after procedure to complete 24 hours.

Drug: Lactated Ringer's solution

Interventions

Lactated Ringer's solution DRUG

Standard fluid hydration with Lactated Ringer's solution is calculated based on Holiday Segar's equation Aggressive hydration with Lactated Ringer's solution is defined as administration of 150 ml/hour of fluid

Also known as: Ringer's Lactated solution

aggressive hydration; standard hydration

Eligibility Criteria

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

You may qualify if:

• patients at age between 18-65 years old undergoing first time ERCP

You may not qualify if:

• Ongoing acute pancreatitis
• Chronic pancreaittis
• Prior sphincterotomy
• Ongoing hypotension including those with sepsis
• Cardiac insufficiency (CI, \>NYHA Class II heart failure)
• Renal insufficiency (RI, creatinine clearance \<40mL/min)
• Severe liver dysfunction (albumin \< 3mg/dL)
• Respiratory insufficiency (defined as oxygen saturation \< 90%)
• Pregnancy
• Hyponatremia (Na+ levels \< 130mEq/L))
• Hypernatremia (Na+ levels \> 150mEq/L)

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (4)

• Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.

  PMID: 22494121 BACKGROUND

• Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N, Laine L. Aggressive hydration with lactated Ringer's solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2014 Feb;12(2):303-7.e1. doi: 10.1016/j.cgh.2013.07.026. Epub 2013 Aug 3.

  PMID: 23920031 BACKGROUND

• Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8. doi: 10.1016/j.gie.2005.04.015. No abstract available.

  PMID: 15990812 BACKGROUND

• Chang A, Pausawasdi N, Charatcharoenwitthaya P, Kaosombatwattana U, Sriprayoon T, Limsrivilai J, Prachayakul V, Leelakusolvong S. Continuous Infusion of Fluid Hydration Over 24 Hours Does Not Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis. Dig Dis Sci. 2022 Aug;67(8):4122-4130. doi: 10.1007/s10620-021-07256-z. Epub 2021 Oct 15.

  PMID: 34655014 DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Nonthalee Pausawasdi, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: July 1, 2016
• Study Start: August 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 28, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)