Goal-directed Fluid Resuscitation in Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00853515
• Other study ID #: 2008-P-001757
• Status: Terminated
• Phase: N/A
• First received: February 27, 2009
• Last updated: December 8, 2016
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: December 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Other:
• Goal-directed fluid resuscitation
Targeted, weight-based fluid resuscitation

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours		first 24 hours of hospitalization	No