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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

February 27, 2009
July 7, 2010
March 2009
February 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00853515 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Goal-directed Fluid Resuscitation in Acute Pancreatitis
A Randomized-controlled Trial of a Targeted Approach to Fluid Resuscitation in Acute Pancreatitis

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Pancreatitis
Other: Goal-directed fluid resuscitation
Targeted, weight-based fluid resuscitation
  • Experimental: 1
    Goal-directed fluid resuscitation with lactated Ringer's solution
    Intervention: Other: Goal-directed fluid resuscitation
  • Experimental: 2
    Goal-directed fluid resuscitation with normal saline
    Intervention: Other: Goal-directed fluid resuscitation
  • No Intervention: 3
    Standard fluid resuscitation with lactated Ringer's solution
  • No Intervention: 4
    Standard fluid resuscitation with normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
June 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00853515
2008-P-001757
Yes
Bechien Wu, M.D., M.P.H, Brigham and Women's Hospital
Brigham and Women's Hospital
Dartmouth-Hitchcock Medical Center
Principal Investigator: Bechien U. Wu, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP