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Clinical Trials/NCT00853515
NCT00853515TerminatedNot Applicable

A Randomized-controlled Trial of a Targeted Approach to Fluid Resuscitation in Acute Pancreatitis

Brigham and Women's Hospital2 sites in 1 country40 target enrollmentStarted: March 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
40
Locations
2
Primary Endpoint
Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours

Time Frame: first 24 hours of hospitalization

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bechien Wu, MD, MPH

Bechien Wu, M.D., M.P.H.

Brigham and Women's Hospital

Study Sites (2)

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