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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00731978
First Posted: August 11, 2008
Last Update Posted: October 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hutchinson Technology Inc
  Purpose

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.


Condition Intervention
Colorectal Surgery Procedure: Restricted intraoperative fluid management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Further study details as provided by Hutchinson Technology Inc:

Primary Outcome Measures:
  • Major postoperative complications [ Time Frame: within the first 30 days of the postoperative period ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: InSpectra StO2

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731978


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305-5640
United States, Texas
University of Texas Health Science Center (UTHSCSA)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Hutchinson Technology Inc
Investigators
Principal Investigator: Stephen M Cohn, MD, FACS University of Texas
  More Information

Responsible Party: BethAnn Guthmueller / Clinical Project Manager, Hutchsinson Technology Incorporated
ClinicalTrials.gov Identifier: NCT00731978     History of Changes
Other Study ID Numbers: H0045
First Submitted: August 7, 2008
First Posted: August 11, 2008
Last Update Posted: October 29, 2009
Last Verified: October 2009

Keywords provided by Hutchinson Technology Inc:
Near-Infrared Spectroscopy
Intraoperative Care