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

NCT ID: NCT00731978

Last Updated: 2009-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Standard

Standard intraoperative fluid management

Group Type NO_INTERVENTION

No interventions assigned to this group

Restricted

Restricted intraoperative fluid management

Group Type EXPERIMENTAL

Restricted intraoperative fluid management

Intervention Type PROCEDURE

Intraoperative fluid management guided by Sto2.

Interventions

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Restricted intraoperative fluid management

Intraoperative fluid management guided by Sto2.

Intervention Type PROCEDURE

Other Intervention Names

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InSpectra StO2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hutchinson Technology Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Hutchsinson Technology Incorporated

Principal Investigators

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Stephen M Cohn, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

University of Texas Health Science Center (UTHSCSA)

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H0045

Identifier Type: -

Identifier Source: org_study_id

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