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Goal-directed Fluid Resuscitation in Acute Pancreatitis

NCT ID: NCT00853515

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Goal-directed fluid resuscitation with lactated Ringer's solution

Group Type EXPERIMENTAL

Goal-directed fluid resuscitation

Intervention Type OTHER

Targeted, weight-based fluid resuscitation

2

Goal-directed fluid resuscitation with normal saline

Group Type EXPERIMENTAL

Goal-directed fluid resuscitation

Intervention Type OTHER

Targeted, weight-based fluid resuscitation

3

Standard fluid resuscitation with lactated Ringer's solution

Group Type NO_INTERVENTION

No interventions assigned to this group

4

Standard fluid resuscitation with normal saline

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Goal-directed fluid resuscitation

Targeted, weight-based fluid resuscitation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bechien Wu, MD, MPH

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bechien U. Wu, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2008-P-001757

Identifier Type: -

Identifier Source: org_study_id