NIRF Trial: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial (NIRF)

October 28, 2009 updated by: Hutchinson Technology Inc

Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial A Prospective Randomized Study of Near-infrared Spectroscopy Directed Fluid Therapy vs Standard Fluid Therapy in Patients Undergoing Open Elective Colorectal Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5640
        • Stanford University School of Medicine
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center (UTHSCSA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard
Standard intraoperative fluid management
Experimental: Restricted
Restricted intraoperative fluid management
Procedure: Restricted intraoperative fluid management
Intraoperative fluid management guided by Sto2.
Other Names:
  • InSpectra StO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major postoperative complications
Time Frame: within the first 30 days of the postoperative period
within the first 30 days of the postoperative period

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: within the first 30 days of the postoperative period
within the first 30 days of the postoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hutchinson Technology Inc

Investigators

  • Principal Investigator: Stephen M Cohn, MD, FACS, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

October 29, 2009

Last Update Submitted That Met QC Criteria

October 28, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H0045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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