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Goal-directed Fluid Resuscitation in Acute Pancreatitis

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ClinicalTrials.gov Identifier: NCT00853515
Recruitment Status : Terminated (interim analysis incidence primary endpoint lower than anticipated. Sigicant finding based on secondary endpoint.)
First Posted : March 2, 2009
Last Update Posted : December 9, 2016
Sponsor:
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Bechien Wu, MD, MPH, Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Pancreatitis Other: Goal-directed fluid resuscitation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours [ Time Frame: first 24 hours of hospitalization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: March 2, 2009    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases