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

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.

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Key information

Conditions

Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine, Stanford, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restricted intraoperative fluid management

Procedure

Intraoperative fluid management guided by Sto2.

Other names: InSpectra StO2

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

Time frame: within the first 30 days of the postoperative period

Sponsors and collaborators

Lead sponsor

Hutchinson Technology Inc

Industry

Registry information

Official study 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

Acronym: NIRF

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Aug 11, 2008
Registry last updated: Oct 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed