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Goal-directed Fluid Resuscitation in Acute Pancreatitis

This study has been terminated.
(interim analysis incidence primary endpoint lower than anticipated. Sigicant finding based on secondary endpoint.)
Sponsor:
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00853515
First received: February 27, 2009
Last updated: July 7, 2010
Last verified: July 2010
History of Changes
  Purpose

Vigorous fluid resuscitation is currently believed to play a key role in reducing complications associated with acute pancreatitis. However, aggressive fluid replacement can be associated with complications such as pulmonary fluid sequestration. The purpose of this study is to evaluate alternative approaches to early fluid resuscitation for patients with acute pancreatitis.


Condition Intervention
Acute Pancreatitis
 Other: Goal-directed fluid resuscitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized-controlled Trial of a Targeted Approach to Fluid Resuscitation in Acute Pancreatitis

Resource links provided by NLM:

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours [ Time Frame: first 24 hours of hospitalization ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Goal-directed fluid resuscitation with lactated Ringer's solution
 Other: Goal-directed fluid resuscitation
Targeted, weight-based fluid resuscitation
Experimental: 2
Goal-directed fluid resuscitation with normal saline
 Other: Goal-directed fluid resuscitation
Targeted, weight-based fluid resuscitation
No Intervention: 3
Standard fluid resuscitation with lactated Ringer's solution
No Intervention: 4
Standard fluid resuscitation with normal saline

Detailed Description:

Primary Aim: Evaluate the impact of a goal-directed fluid resuscitation protocol compared to standard fluid resuscitation on systemic inflammation in patients with acute pancreatitis.

Secondary Aim: Evaluate the impact of resuscitation with Lactated Ringer's compared to normal saline on systemic inflammation in acute pancreatitis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute pancreatitis diagnosed by at least 2 criteria
  • adult patients at least 18 years of age

Exclusion Criteria:

  • history of severe cardiovascular, respiratory, renal, hepatic or hematologic/immunologic disease
  • concurrent metabolic or physiologic derangement requiring specific fluid management
  • pregnancy
  • patients transferred from acute care hospital
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853515

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Bechien U. Wu, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Bechien Wu, M.D., M.P.H, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00853515     History of Changes
Other Study ID Numbers: 2008-P-001757
Study First Received: February 27, 2009
Last Updated: July 7, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013