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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:
ClinicalTrials.gov Identifier:
NCT00853515
First Posted: March 2, 2009
Last Update Posted: December 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Bechien Wu, MD, MPH, Brigham and Women's Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Bechien Wu, MD, MPH, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bechien Wu, MD, MPH, 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
First Submitted: February 27, 2009
First Posted: March 2, 2009
Last Update Posted: December 9, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases