NCT00456703

Brief Summary

Liberal intravenous fluid resuscitation during open abdominal surgery may predispose the patients to multiorgan dysfunction, prolong hospital stay and increase postoperative morbidity. The main aim of the study is to assess the safety and feasibility of restricted fluid regimen in open abdominal bowel surgery.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 6, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

April 4, 2007

Last Update Submit

March 3, 2017

Conditions

Bowel Surgery

Keywords

fluids,restriction,infection,bowel surgery,open abdominal

Outcome Measures

Primary Outcomes (1)

  • mixed venous oxygen saturation, acid bases, hemodynamics

    intraoperative period

Secondary Outcomes (1)

  • Wound infection and length of hospital stay

    during the hospital admission

Study Arms (1)

restriction

ACTIVE COMPARATOR

In this group, the fluids will be restricted compared to a standard procedure

Other: intraoperative fluid managementOther: fluid restriction

Interventions

intraoperative fluid managementOTHER

fluid restriction

restriction
fluid restrictionOTHER

restriction of fluids

restriction

Eligibility Criteria

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

You may qualify if:

  • ASA physical status I-III patients coming in for open abdominal bowel surgery

You may not qualify if:

  • Coagulopathy,
  • Pregnancy,
  • Renal insufficiency,
  • Contraindications for placing a central line,
  • ASA IV and V,
  • Age less than 18years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. doi: 10.1097/00000542-200507000-00008.

    PMID: 15983453BACKGROUND

  • Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

    PMID: 11794169BACKGROUND

MeSH Terms

Conditions

Infections

Study Officials

  • Balachundhar Subramaniam, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anaesthesia

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

March 6, 2017

Record last verified: 2017-03

Locations

US(1)