Colorectal SurgeryNIRFNCT00731978
NIRF Trial: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial
A study testing Restricted intraoperative fluid management in people with Colorectal Surgery, run by Hutchinson Technology Inc at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Restricted intraoperative fluid management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective open colorectal surgery
- Age greater than or equal to 18 years
- Low to moderate risk colorectal surgery patients
Who cannot join
- Unacceptable Baseline vital sign measurements
- High risk colorectal surgery patients
- Jehovah's Witness
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Health Science Center (UTHSCSA)
San Antonio, Texas, 78229
Stanford University School of Medicine
Stanford, California, 94305-5640
About this study
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
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.
- Conditions
- Colorectal Surgery
- Being tested
- Restricted intraoperative fluid management
- Keywords
- Near-Infrared Spectroscopy, Intraoperative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restricted intraoperative fluid managementProcedure or surgery
Also called InSpectra StO2
Intraoperative fluid management guided by Sto2.
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Standard intraoperative fluid management |
| Restricted | Experimental | Restricted intraoperative fluid management Receives: Procedure: Restricted intraoperative fluid management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major postoperative complications
Measured: within the first 30 days of the postoperative period
Secondary outcomes (1)
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
Measured: within the first 30 days of the postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchinson Technology Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stephen M Cohn, MD, FACS, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731978
- Sponsor's protocol ID
- H0045
- Acronym
- NIRF
- Status last verified
- Oct 2009
- First submitted
- 7 Aug 2008
- Last updated
- 29 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00731978
- Acronym / sponsor ID
- NIRF / H0045
- Conditions
- Colorectal Surgery
- Keywords
- Near-Infrared Spectroscopy, Intraoperative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hutchinson Technology IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Standard intraoperative fluid management |
| Restricted | Experimental | Procedure: Restricted intraoperative fluid managementRestricted intraoperative fluid management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for elective open colorectal surgery
- Age greater than or equal to 18 years
- Low to moderate risk colorectal surgery patients
Key exclusion criteria (3 listed)
- Unacceptable Baseline vital sign measurements
- High risk colorectal surgery patients
- Jehovah's Witness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restricted intraoperative fluid managementAlso: InSpectra StO2Intraoperative fluid management guided by Sto2. | Procedure or surgery | Restricted |
Primary outcome
Major postoperative complications
Time frame: within the first 30 days of the postoperative period
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen M Cohn, MD, FACS principal investigator
University of Texas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restricted intraoperative fluid management in people with Colorectal Surgery, run by Hutchinson Technology Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major postoperative complications (time frame: within the first 30 days of the postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2009.