High Volume Lactated Ringer's Solution and Pancreatitis
NCT ID: NCT02050048
Last Updated: 2019-09-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
26 participants
INTERVENTIONAL
2014-01-31
2016-01-31
Brief Summary
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Detailed Description
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We plan on enrolling 1,400 consecutive high risk patients undergoing ERCP. We are assuming a baseline PEP risk of 9.2%. Fluid administration will be based on Ideal Body Weight (IBW) in order to standardize the aggressive fluid administration across all body weights and reduce the potential for adverse cardiopulmonary outcomes.
All participants will be monitored for 90 minutes following their procedure to assess the development of any adverse symptoms. Analysis by a data safety monitoring board (DSMB) will take place throughout the study. The DSMB is comprised of a panel of experts independent of NorthShore University HealthSystem.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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High Volume Group (Intervention Arm)
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
* initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
* LR fluid infusion during the procedure at 5 cc/kg/hr
* Post-procedure bolus of 20 cc/kg over 90 minutes
Administration of Lactated Ringer's (LR) Solution
Patients will be randomized to low volume or high volume group. Patient in the low volume group will receive fluids via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
* initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
* LR fluid infusion during the procedure at 5 cc/kg/hr
* Post-procedure bolus of 20 cc/kg over 90 minutes
Low Volume Group (Control Arm)
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
Administration of Lactated Ringer's (LR) Solution
Patients will be randomized to low volume or high volume group. Patient in the low volume group will receive fluids via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
* initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
* LR fluid infusion during the procedure at 5 cc/kg/hr
* Post-procedure bolus of 20 cc/kg over 90 minutes
Interventions
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Administration of Lactated Ringer's (LR) Solution
Patients will be randomized to low volume or high volume group. Patient in the low volume group will receive fluids via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
* initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
* LR fluid infusion during the procedure at 5 cc/kg/hr
* Post-procedure bolus of 20 cc/kg over 90 minutes
Eligibility Criteria
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Inclusion Criteria
* Clinical suspicion of sphincter of Oddi dysfunction
* History of post-ERCP pancreatitis (at least one episode)
* Pancreatic sphincterotomy
* Pre-cut (access) sphincterotomy
* Ampullectomy
Exclusion Criteria
* Intrauterine pregnancy or breastfeeding mother
* Congestive heart failure
* Advanced/symptomatic coronary artery disease
* Known ascites
* Renal failure
* Active or recent gastrointestinal hemorrhage
* Acute pancreatitis within 72 hours prior to ERCP
18 Years
ALL
No
Sponsors
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Medical College of Wisconsin
OTHER
Allina Health System
OTHER
Wake Forest University Health Sciences
OTHER
University of Utah
OTHER
Endeavor Health
OTHER
Responsible Party
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Rachel Pulido
Russelll Brown, M.D.
Principal Investigators
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Russell Brown, MD
Role: PRINCIPAL_INVESTIGATOR
Endeavor Health
Mick Meiselman, MD
Role: STUDY_DIRECTOR
Central Coast Gastroenterology
Zachary Smith, MD
Role: STUDY_DIRECTOR
Medical College of Wisconsin
Locations
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NorthShore University HealthSystem
Evanston, Illinois, United States
NorthShore University HealthSystem
Highland Park, Illinois, United States
Advocate Health Care
Skokie, Illinois, United States
Minnesota Gastroenterology
Plymouth, Minnesota, United States
University of Utah Health Care
Salt Lake City, Utah, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.
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.
Feurer ME, Adler DG. Post-ERCP pancreatitis: review of current preventive strategies. Curr Opin Gastroenterol. 2012 May;28(3):280-6. doi: 10.1097/MOG.0b013e3283528e68.
Choudhary A, Bechtold ML, Arif M, Szary NM, Puli SR, Othman MO, Pais WP, Antillon MR, Roy PK. Pancreatic stents for prophylaxis against post-ERCP pancreatitis: a meta-analysis and systematic review. Gastrointest Endosc. 2011 Feb;73(2):275-82. doi: 10.1016/j.gie.2010.10.039.
Fazel A, Quadri A, Catalano MF, Meyerson SM, Geenen JE. Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study. Gastrointest Endosc. 2003 Mar;57(3):291-4. doi: 10.1067/mge.2003.124.
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.
Gardner TB, Vege SS, Pearson RK, Chari ST. Fluid resuscitation in acute pancreatitis. Clin Gastroenterol Hepatol. 2008 Oct;6(10):1070-6. doi: 10.1016/j.cgh.2008.05.005. Epub 2008 Jul 10.
Warndorf MG, Kurtzman JT, Bartel MJ, Cox M, Mackenzie T, Robinson S, Burchard PR, Gordon SR, Gardner TB. Early fluid resuscitation reduces morbidity among patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):705-9. doi: 10.1016/j.cgh.2011.03.032. Epub 2011 Apr 8.
Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, Overby CS, Aas J, Ryan ME, Bochna GS, Shaw MJ, Snady HW, Erickson RV, Moore JP, Roel JP. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc. 2001 Oct;54(4):425-34. doi: 10.1067/mge.2001.117550.
de-Madaria E, Soler-Sala G, Sanchez-Paya J, Lopez-Font I, Martinez J, Gomez-Escolar L, Sempere L, Sanchez-Fortun C, Perez-Mateo M. Influence of fluid therapy on the prognosis of acute pancreatitis: a prospective cohort study. Am J Gastroenterol. 2011 Oct;106(10):1843-50. doi: 10.1038/ajg.2011.236. Epub 2011 Aug 30.
Nasr JY, Papachristou GI. Early fluid resuscitation in acute pancreatitis: a lot more than just fluids. Clin Gastroenterol Hepatol. 2011 Aug;9(8):633-4. doi: 10.1016/j.cgh.2011.03.010. Epub 2011 Mar 21. No abstract available.
Wu M, Jiang S, Lu X, Zhong Y, Song Y, Fan Z, Kang X. Aggressive hydration with lactated ringer solution in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review and meta-analysis. Medicine (Baltimore). 2021 Apr 23;100(16):e25598. doi: 10.1097/MD.0000000000025598.
Other Identifiers
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EH 13-130
Identifier Type: -
Identifier Source: org_study_id
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