Goal-directed Fluid Resuscitation in Acute Pancreatitis

December 8, 2016 updated by: Bechien Wu, MD, MPH, Brigham and Women's Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours
Time Frame: first 24 hours of hospitalization
first 24 hours of hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Bechien U. Wu, MD, MPH, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (Estimate)

March 2, 2009

Study Record Updates

Last Update Posted (Estimate)

December 9, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-P-001757

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe