Goal-directed Fluid Resuscitation in Acute Pancreatitis | NCT00853515

Studies
Goal-directed Fluid Resuscitation in Acute Pancreatitis

NCT00853515

Sponsor

Brigham and Women's Hospital

Status

Terminated

Last Update Posted

Dec 9, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Acute Pancreatitis

Interventions

Goal-directed fluid resuscitation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Feb 27, 2009

First Submission Date that Met QC Criteria

Feb 27, 2009

First Posted Date

Mar 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2016

Last Update Posted Date

Dec 9, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bechien Wu, MD, MPH, Bechien Wu, M.D., M.P.H., Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Name	Class
Dartmouth-Hitchcock Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Goal-directed fluid resuscitation	Other	Targeted, weight-based fluid resuscitation	1 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bechien U. Wu, MD, MPH	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided