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

Colorectal Surgery Clinical Trial

— NIRF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731978
• Other study ID #: H0045
• Status: Completed
• Phase: N/A
• First received: August 7, 2008
• Last updated: October 28, 2009
• Start date: September 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Hutchinson Technology Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Procedure:
• Restricted intraoperative fluid management
Intraoperative fluid management guided by Sto2.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center (UTHSCSA)	San Antonio	Texas
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Hutchinson Technology Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major postoperative complications		within the first 30 days of the postoperative period	No
Secondary	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	No