- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00731978
NIRF Trial: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial (NIRF)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Intraoperative fluid management guided by Sto2.
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Stephen M Cohn, MD, FACS, University of Texas
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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