NCT01761539

Brief Summary

Fluid resuscitation for pancreatitis is recommended given evidence that hemoconcentration is associated with necrosis. However, there is insufficient evidence to support whether resuscitation should be moderate or aggressive. In this study the investigators aim to compare the clinical outcome associated with these strategies in a clinical randomized fashion to determine the optimal treatment of acute pancreatitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

August 2, 2016

Status Verified

July 1, 2016

Enrollment Period

2.6 years

First QC Date

January 3, 2013

Last Update Submit

July 31, 2016

Conditions

Pancreatitis

Keywords

pancreatitispancreatitis, alcoholic

Outcome Measures

Primary Outcomes (1)

  • Clinical Improvement

    Decreased hematocrit, BUN, Cr compared to time zero, decreased epigastric pain, and ability to tolerate PO's.

    36 hours

Secondary Outcomes (5)

  • Time to reach clinical improvement

    36 hours

  • Requirement for aggressive hydration

    36 hours

  • Systemic Inflammatory Response Syndrome (SIRS)

    36 hours

  • Severe Pancreatitis

    36 hours

  • Fluid Overload

    36 hours

Study Arms (2)

Aggressive Hydration

EXPERIMENTAL

Receives Lactated Ringers solution at 3cc/kg/hr following an initial 20cc/kg bolus.

Other: Aggressive Hydration

Moderate Hydration

ACTIVE COMPARATOR

Receives Lactated Ringers solution at 1.5cc/kg/hr following an initial 10cc/kg bolus.

Other: Moderate Hydration

Interventions

Aggressive HydrationOTHER

Receives 20cc/kg bolus and 3cc/kg/hr thereafter.

Aggressive Hydration
Moderate HydrationOTHER

Receives 10cc/kg bolus and 1.5cc/kg/hr thereafter.

Moderate Hydration

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild to moderate pancreatitis

You may not qualify if:

  • SIRS (2/4) a) HR \>90 b) RR\>20 or paCO2 \<32 on room air c) T\>100.4 F \<96.8 F d) WBC \>12, \<4 or \>10%
  • severe pancreatitis
  • renal insufficiency, Cr \>2 mg/dl
  • cardiac insufficiency
  • respiratory insufficiency, O2 saturation \<90% room air
  • liver dysfunction, aklbumin \<3mg/dL
  • pregnancy
  • hyponatremia, Na \< 135meq/L
  • clinical findings of volume overload peripheral edema ascites
  • pancreatitis following endoscopic, radiographic, or surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

Location

Related Publications (17)

  • 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: 21554987BACKGROUND

  • 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: 21421079BACKGROUND

  • 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: 18619920BACKGROUND

  • 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: 12123089BACKGROUND

  • Muddana V, Whitcomb DC, Khalid A, Slivka A, Papachristou GI. Elevated serum creatinine as a marker of pancreatic necrosis in acute pancreatitis. Am J Gastroenterol. 2009 Jan;104(1):164-70. doi: 10.1038/ajg.2008.66.

    PMID: 19098865BACKGROUND

  • Wu BU, Johannes RS, Sun X, Conwell DL, Banks PA. Early changes in blood urea nitrogen predict mortality in acute pancreatitis. Gastroenterology. 2009 Jul;137(1):129-35. doi: 10.1053/j.gastro.2009.03.056. Epub 2009 Apr 1.

    PMID: 19344722BACKGROUND

  • Singh VK, Bollen TL, Wu BU, Repas K, Maurer R, Yu S, Mortele KJ, Conwell DL, Banks PA. An assessment of the severity of interstitial pancreatitis. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1098-103. doi: 10.1016/j.cgh.2011.08.026. Epub 2011 Sep 3.

    PMID: 21893128BACKGROUND

  • Singh VK, Wu BU, Bollen TL, Repas K, Maurer R, Johannes RS, Mortele KJ, Conwell DL, Banks PA. A prospective evaluation of the bedside index for severity in acute pancreatitis score in assessing mortality and intermediate markers of severity in acute pancreatitis. Am J Gastroenterol. 2009 Apr;104(4):966-71. doi: 10.1038/ajg.2009.28. Epub 2009 Mar 17.

    PMID: 19293787BACKGROUND

  • Gardner TB, Vege SS, Chari ST, Petersen BT, Topazian MD, Clain JE, Pearson RK, Levy MJ, Sarr MG. Faster rate of initial fluid resuscitation in severe acute pancreatitis diminishes in-hospital mortality. Pancreatology. 2009;9(6):770-6. doi: 10.1159/000210022. Epub 2010 Jan 21.

    PMID: 20110744BACKGROUND

  • 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: 21876561BACKGROUND

  • Wu BU. Editorial: fluid resuscitation in acute pancreatitis: striking the right balance. Am J Gastroenterol. 2011 Oct;106(10):1851-2. doi: 10.1038/ajg.2011.241.

    PMID: 21979206BACKGROUND

  • Mao EQ, Tang YQ, Fei J, Qin S, Wu J, Li L, Min D, Zhang SD. Fluid therapy for severe acute pancreatitis in acute response stage. Chin Med J (Engl). 2009 Jan 20;122(2):169-73.

    PMID: 19187641BACKGROUND

  • Eckerwall G, Olin H, Andersson B, Andersson R. Fluid resuscitation and nutritional support during severe acute pancreatitis in the past: what have we learned and how can we do better? Clin Nutr. 2006 Jun;25(3):497-504. doi: 10.1016/j.clnu.2005.10.012. Epub 2005 Dec 5.

    PMID: 16337067BACKGROUND

  • 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: 21645639BACKGROUND

  • de-Madaria E, Soler-Sala G, Lopez-Font I, Zapater P, Martinez J, Gomez-Escolar L, Sanchez-Fortun C, Sempere L, Perez-Lopez J, Lluis F, Perez-Mateo M. Update of the Atlanta Classification of severity of acute pancreatitis: should a moderate category be included? Pancreatology. 2010;10(5):613-9. doi: 10.1159/000308795. Epub 2010 Oct 30.

    PMID: 21042037BACKGROUND

  • Balthazar EJ. Acute pancreatitis: assessment of severity with clinical and CT evaluation. Radiology. 2002 Jun;223(3):603-13. doi: 10.1148/radiol.2233010680.

    PMID: 12034923BACKGROUND

  • 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: 2070995BACKGROUND

MeSH Terms

Conditions

PancreatitisPancreatitis, Alcoholic

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • James L Buxbaum, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Endoscopy, Los Angeles County Hospital

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 4, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

August 2, 2016

Record last verified: 2016-07

Locations

US(1)