NCT00853515

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

February 27, 2009

Last Update Submit

December 8, 2016

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

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

    first 24 hours of hospitalization

Study Arms (4)

1

EXPERIMENTAL

Goal-directed fluid resuscitation with lactated Ringer's solution

Other: Goal-directed fluid resuscitation

2

EXPERIMENTAL

Goal-directed fluid resuscitation with normal saline

Other: Goal-directed fluid resuscitation

3

NO INTERVENTION

Standard fluid resuscitation with lactated Ringer's solution

4

NO INTERVENTION

Standard fluid resuscitation with normal saline

Interventions

Goal-directed fluid resuscitationOTHER

Targeted, weight-based fluid resuscitation

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute pancreatitis diagnosed by at least 2 criteria
  • adult patients at least 18 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Bechien U. Wu, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bechien Wu, M.D., M.P.H.

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 2, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2010

Study Completion

June 1, 2010

Last Updated

December 9, 2016

Record last verified: 2016-12

Locations

US(1)