NCT00731978

Brief Summary

The purpose of this study is to evaluate if the InSpectra StO2 Monitor can safely guide the amount of fluid needed during colorectal surgery. The study hypothesis is that intraoperative fluid limitation can be safely accomplished when guided by StO2 monitoring, and that this fluid restriction regimen will result in a reduction in postoperative morbidity when compared to standard monitoring and fluid therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

2 active sites

Status
completed

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

August 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 29, 2009

Status Verified

October 1, 2009

Enrollment Period

7 months

First QC Date

August 7, 2008

Last Update Submit

October 28, 2009

Conditions

Colorectal Surgery

Keywords

Near-Infrared SpectroscopyIntraoperative Care

Outcome Measures

Primary Outcomes (1)

  • Major postoperative complications

    within the first 30 days of the postoperative period

Secondary Outcomes (1)

  • StO2 changes during intraoperative fluid management, hospital-free days, surgical site infections, time to first bowel movement, total fluid and total intraoperative fluid volumes, daily fluid volumes through 3 days postoperative, daily weights

    within the first 30 days of the postoperative period

Study Arms (2)

Standard

NO INTERVENTION

Standard intraoperative fluid management

Restricted

EXPERIMENTAL

Restricted intraoperative fluid management

Procedure: Restricted intraoperative fluid management

Interventions

Restricted intraoperative fluid managementPROCEDURE

Intraoperative fluid management guided by Sto2.

Also known as: InSpectra StO2
Restricted

Eligibility Criteria

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

You may qualify if:

  • Scheduled for elective open colorectal surgery
  • Age greater than or equal to 18 years
  • Low to moderate risk colorectal surgery patients

You may not qualify if:

  • Unacceptable Baseline vital sign measurements
  • High risk colorectal surgery patients
  • Jehovah's Witness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305-5640, United States

Location

University of Texas Health Science Center (UTHSCSA)

San Antonio, Texas, 78229, United States

Location

Study Officials

  • Stephen M Cohn, MD, FACS

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 11, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2009

Study Completion

October 1, 2009

Last Updated

October 29, 2009

Record last verified: 2009-10

Locations

US(2)