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Goal-directed Fluid Resuscitation in Acute Pancreatitis

Primary Purpose

Acute Pancreatitis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Goal-directed fluid resuscitation

About this trial

This is an interventional treatment trial for Acute Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

Goal-directed fluid resuscitation with lactated Ringer's solution

Goal-directed fluid resuscitation with normal saline

Standard fluid resuscitation with lactated Ringer's solution

Standard fluid resuscitation with normal saline

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00853515

First Posted

February 27, 2009

Last Updated

December 8, 2016

Sponsor

Brigham and Women's Hospital

Collaborators

Dartmouth-Hitchcock Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00853515

Brief Title

Goal-directed Fluid Resuscitation in Acute Pancreatitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Terminated

Why Stopped

interim analysis incidence primary endpoint lower than anticipated. Sigicant finding based on secondary endpoint.

Study Start Date

March 2009 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pancreatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Goal-directed fluid resuscitation with lactated Ringer's solution

Arm Title

Arm Type

Experimental

Arm Description

Goal-directed fluid resuscitation with normal saline

Arm Title

Arm Type

No Intervention

Arm Description

Standard fluid resuscitation with lactated Ringer's solution

Arm Title

Arm Type

No Intervention

Arm Description

Standard fluid resuscitation with normal saline

Intervention Type

Other

Intervention Name(s)

Goal-directed fluid resuscitation

Intervention Description

Targeted, weight-based fluid resuscitation

Primary Outcome Measure Information:

Title

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

Time Frame

first 24 hours of hospitalization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bechien U. Wu, MD, MPH

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

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Goal-directed Fluid Resuscitation in Acute Pancreatitis

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