NCT00731978CompletedNot Applicable
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
Hutchinson Technology Inc4 sites in 1 country27 target enrollmentStarted: September 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 4
- Primary Endpoint
- Major postoperative complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Major postoperative complications
Time Frame: within the first 30 days of the postoperative period
Secondary Outcomes
- 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)
Investigators
Study Sites (4)
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