Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis
Primary Purpose
Pancreatitis
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Lactated Ringer's solution
Sponsored by
About this trial
This is an interventional prevention trial for Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- patients at age between 18-65 years old undergoing first time ERCP
Exclusion Criteria:
- 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)
Sites / Locations
- Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
standard hydration
aggressive hydration
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
severity of post ERCP pancreatitis
severity is defined by length of hospital stay, mild pancreatitis is defined by hospitalization of 48 hours, moderate pancreatitis is defined by hospitalization of more than 48 hours without additional intervention, severe pancreatitis is defined by hospitalization of greater than 72 hours and/or requiring intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02821546
Brief Title
Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis
Official Title
Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Patients underwent first-time ERCP were randomly assigned (1:1) to receive either LRS at a rate of 150 ml/hr starting 2 hours prior to procedure, and continued during and after procedure to complete 24 hours (aggressive hydration) or LRS at a rate calculated by the Holliday-Segar method given peri-procedurally as described earlier (standard hydration). Visual analog scale, serum amylase, lipase, C-reactive protein (CRP), and urine analysis were assessed prior to procedure and 24 hours after. The primary endpoint was post ERCP pancreatitis defined as new or increased epigastric pain persisting for ≥24 hours, elevation of amylase or lipase >3 times the upper limit of normal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard hydration
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
aggressive hydration
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer's solution
Other Intervention Name(s)
Ringer's Lactated solution
Intervention Description
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
Primary Outcome Measure Information:
Title
post ERCP pancreatitis
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
severity of post ERCP pancreatitis
Description
severity is defined by length of hospital stay, mild pancreatitis is defined by hospitalization of 48 hours, moderate pancreatitis is defined by hospitalization of more than 48 hours without additional intervention, severe pancreatitis is defined by hospitalization of greater than 72 hours and/or requiring intervention
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients at age between 18-65 years old undergoing first time ERCP
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nonthalee Pausawasdi, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22494121
Citation
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.
Results Reference
background
PubMed Identifier
23920031
Citation
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.
Results Reference
background
PubMed Identifier
15990812
Citation
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.
Results Reference
background
PubMed Identifier
34655014
Citation
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.
Results Reference
derived
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Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis
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