Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis

NCT01758549 | Completed DMC

• 1 other identifier: HS-10-00576
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.ERCP is a commonly performed endoscopic procedure used to treat stones and blockages of the bile duct as well as to manage leaks which occurs following laparoscopic gallbladder removal.
2. 2.Post ERCP pancreatitis (PEP) complicates 5-15% of biliary endoscopic procedures and results in considerable suffering and cost.
3. 3.Patients with acute pancreatitis are treated with fluids.
4. 4.Our aim is to assess whether prophylactic treatment with aggressive intravenous hydration prevents ERCP pancreatitis.
5. 5.In a blinded fashion patients will be randomized to aggressive intravenous versus moderate hydration during and aftere ERCP for standard clinical indications.

Conditions

Pancreatitis

Keywords

pancreatitis; cholangiopancreatography, endoscopic retrograde; hyperamylasemia

Outcome Measures

Primary Outcomes (1)

• Acute Pancreatitis

  The primary endpoint is post ERCP pancreatitis which is defined as increased abdominal pain and a serum amylase level three times the upper limit of normal (3xULN). Increased pain will be defined as an increase in the visual analog pain score compared to the value immediately prior to ERCP

  24 hours

Secondary Outcomes (3)

• Clinical volume overload

  24 hours

• Serum amylase three times the upper limit of normal

  24 hours

• Increased abdominal pain

  24 hours

Study Arms (2)

Aggressive Intravenous Hydration Group

EXPERIMENTAL

Patients randomized to the aggressive intravenous hydration group receive lactated ringers (LR) IV at 3 mL kg-1 hr-1 during the procedure, a 20cc/kg LR IV bolus immediately afterward, and LR IV at 3 mL kg-1 hr-1 for 8 hours following the procedure.

Other: Aggressive Intravenous Hydration Group

Standard Fluids Arm

ACTIVE COMPARATOR

Those in the control arm receive standard fluids defined as LR at 1.5 mL kg-1 hr-1 during the procedure and for 8 hours afterwards.

Other: Standard Fluids Arm

Interventions

Aggressive Intravenous Hydration Group OTHER

Patients in the intravenous hydration group wll be treated with lactated ringer infusion at a rate of 3cc/kg/hour during the procedure, be given a bolus of 20cc/kg immediately afterward and receive an infusion of 3cc/kg/hour for 8 hours after the procedure.

Aggressive Intravenous Hydration Group

Standard Fluids Arm OTHER

Patients randomized to the standard fluids arm will receive lactated ringers at an infusion rate of 1.5cc/kg/hour during the procedure, will receive no bolus, and will receive an infusion of lactated ringers at 1.5cc/kg for 8 hours after the procedure.

Standard Fluids Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Inpatients aged 18 to 70 years undergoing ERCP for the first time
• Patients undergoing ERCP for standard clinical indications

You may not qualify if:

• Ongoing acute pancreatitis
• 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%)
• Greater than 70 years of age
• Pregnancy
• Hyponatremia (Na+ levels \< 135mEq/L))
• Hypernatremia (Na+ levels \> 150mEq/L) will be excluded.
• Edema or anasarca
• Ascites

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

Location

Related Publications (16)

• 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

• Reddy N, Wilcox CM, Tamhane A, Eloubeidi MA, Varadarajulu S. Protocol-based medical management of post-ERCP pancreatitis. J Gastroenterol Hepatol. 2008 Mar;23(3):385-92. doi: 10.1111/j.1440-1746.2007.05180.x.

  PMID: 18318823 BACKGROUND

• Andriulli A, Leandro G, Federici T, Ippolito A, Forlano R, Iacobellis A, Annese V. Prophylactic administration of somatostatin or gabexate does not prevent pancreatitis after ERCP: an updated meta-analysis. Gastrointest Endosc. 2007 Apr;65(4):624-32. doi: 10.1016/j.gie.2006.10.030.

  PMID: 17383459 BACKGROUND

• Badalov N, Tenner S, Baillie J. The Prevention, recognition and treatment of post-ERCP pancreatitis. JOP. 2009 Mar 9;10(2):88-97. No abstract available.

  PMID: 19287099 BACKGROUND

• Banks PA, Freeman ML; Practice Parameters Committee of the American College of Gastroenterology. Practice guidelines in acute pancreatitis. Am J Gastroenterol. 2006 Oct;101(10):2379-400. doi: 10.1111/j.1572-0241.2006.00856.x. No abstract available.

  PMID: 17032204 BACKGROUND

• Brown A, Baillargeon JD, Hughes MD, Banks PA. Can fluid resuscitation prevent pancreatic necrosis in severe acute pancreatitis? Pancreatology. 2002;2(2):104-7. doi: 10.1159/000055899.

  PMID: 12123089 BACKGROUND

• Cheng CL, Sherman S, Watkins JL, Barnett J, Freeman M, Geenen J, Ryan M, Parker H, Frakes JT, Fogel EL, Silverman WB, Dua KS, Aliperti G, Yakshe P, Uzer M, Jones W, Goff J, Lazzell-Pannell L, Rashdan A, Temkit M, Lehman GA. Risk factors for post-ERCP pancreatitis: a prospective multicenter study. Am J Gastroenterol. 2006 Jan;101(1):139-47. doi: 10.1111/j.1572-0241.2006.00380.x.

  PMID: 16405547 BACKGROUND

• Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.

  PMID: 2070995 BACKGROUND

• Foitzik T, Hotz HG, Schmidt J, Klar E, Warshaw AL, Buhr HJ. Effect of microcirculatory perfusion on distribution of trypsinogen activation peptides in acute experimental pancreatitis. Dig Dis Sci. 1995 Oct;40(10):2184-8. doi: 10.1007/BF02209003.

  PMID: 7587786 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

• Hendeles L, Sherman J. Are inhaled corticosteroids effective for acute exacerbations of asthma in children? J Pediatr. 2003 Feb;142(2 Suppl):S26-32; discussion S32-3. doi: 10.1067/mpd.2003.23.

  PMID: 12584517 BACKGROUND

• Kusterer K, Enghofer M, Zendler S, Blochle C, Usadel KH. Microcirculatory changes in sodium taurocholate-induced pancreatitis in rats. Am J Physiol. 1991 Feb;260(2 Pt 1):G346-51. doi: 10.1152/ajpgi.1991.260.2.G346.

  PMID: 1996652 BACKGROUND

• Sherman S, Blaut U, Watkins JL, Barnett J, Freeman M, Geenen J, Ryan M, Parker H, Frakes JT, Fogel EL, Silverman WB, Dua KS, Aliperti G, Yakshe P, Uzer M, Jones W, Goff J, Earle D, Temkit M, Lehman GA. Does prophylactic administration of corticosteroid reduce the risk and severity of post-ERCP pancreatitis: a randomized, prospective, multicenter study. Gastrointest Endosc. 2003 Jul;58(1):23-9. doi: 10.1067/mge.2003.307.

  PMID: 12838216 BACKGROUND

• Sutton VR, Hong MK, Thomas PR. Using the 4-hour Post-ERCP amylase level to predict post-ERCP pancreatitis. JOP. 2011 Jul 8;12(4):372-6.

  PMID: 21737899 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

• 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 DERIVED

MeSH Terms

Conditions

Pancreatitis; Hyperamylasemia

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James L Buxbaum, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy, University of Southern California

Study Record Dates

• First Submitted: November 25, 2012
• First Posted: January 1, 2013
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 1, 2014

Record last verified: 2014-06

Locations

US (1)