High Volume Lactated Ringer's Solution and Pancreatitis

NCT02050048 | Terminated Phase 2 Results DMC

• 1 other identifier: EH 13-130
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to examine whether giving large amounts of intravenous (IV) fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis (PEP). Pancreatitis is inflammation of the pancreas, and it is the most frequent serious complication of ERCP. Typically, a small amount of IV fluids are given during this procedure (\~ 1 liter). We are testing whether using a larger amount of fluids (2 - 3 liters) will reduce the risk of PEP.

Conditions

Pancreatitis

Keywords

Pancreatitis; Endoscopic retrograde cholangiopancreatography; Cholangiopancreatography, Endoscopic Retrograde; ERCP; High Volume; Lactated Ringer; Intravenous Administration; Sphincterotomy, Endoscopic; Pancreas

Outcome Measures

Primary Outcomes (1)

• Development of Post-ERCP Pancreatitis

  Patients will be monitored after procedure to see if they develop abdominal pain. If so, serum amylase and lipase blood draws will be completed at least once every 24 hours following procedure to monitor the development of post-ERCP pancreatitis. If patients do not develop abdominal pain following the procedure, research staff will follow up with the patients 5 days and 29 days after the procedure to evaluate for the development of post-ERCP pancreatitis and other related or unrelated complications.

  Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure

Secondary Outcomes (1)

• Number of Participants With Adverse Events Related to Fluid Overload

  Phase II portion (~1 year)

Study Arms (2)

High Volume Group (Intervention Arm)

EXPERIMENTAL

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

Other: Administration of Lactated Ringer's (LR) Solution

Low Volume Group (Control Arm)

ACTIVE COMPARATOR

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.

Other: Administration of Lactated Ringer's (LR) Solution

Interventions

Administration of Lactated Ringer's (LR) Solution OTHER

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

High Volume Group (Intervention Arm); Low Volume Group (Control Arm)

Eligibility Criteria

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

You may qualify if:

• Patients to be included in the study are those undergoing ERCP with the following:
• Clinical suspicion of sphincter of Oddi dysfunction
• History of post-ERCP pancreatitis (at least one episode)
• Pancreatic sphincterotomy
• Pre-cut (access) sphincterotomy
• Ampullectomy

You may not qualify if:

• Age \< 18 years old
• 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

Sponsors & Collaborators

• Endeavor Health: lead
• Medical College of Wisconsin: collaborator
• Allina Health System: collaborator
• Wake Forest University Health Sciences: collaborator
• University of Utah: collaborator

Study Sites (6)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

NorthShore University HealthSystem

Highland Park, Illinois, 60035, United States

Location

Advocate Health Care

Skokie, Illinois, 60076, United States

Location

Minnesota Gastroenterology

Plymouth, Minnesota, 55446, United States

Location

University of Utah Health Care

Salt Lake City, Utah, 84132, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (12)

• 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.

  PMID: 8782497 BACKGROUND

• 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

• 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.

  PMID: 22450899 BACKGROUND

• 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.

  PMID: 21295641 BACKGROUND

• 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.

  PMID: 12612504 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

• 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.

  PMID: 18619920 BACKGROUND

• 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.

  PMID: 21554987 BACKGROUND

• 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.

  PMID: 11577302 BACKGROUND

• 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.

  PMID: 21876561 BACKGROUND

• 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.

  PMID: 21421079 BACKGROUND

• 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.

  PMID: 33879722 DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Solutions

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Limitations and Caveats

Due to low study enrollment, the study was terminated early. Beacuse only 26 subjects were enrolled, the study results may not be statistically significant.

Results Point of Contact

• Title: Dr. Russell Brown
• Organization: NorthShore Univeristy HealthSystem

rbrown@northshore.org

847-657-1900

Study Officials

• Russell Brown, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

• Mick Meiselman, MD

  Central Coast Gastroenterology

  STUDY DIRECTOR

• Zachary Smith, MD

  Medical College of Wisconsin

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Russelll Brown, M.D.

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 30, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 6, 2019
• Results First Posted: April 29, 2016

Record last verified: 2019-08

Locations

US (6)