Abdominal SurgeryNCT00683150
Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring
An observational study of Abdominal Surgery and Thoracic Surgery, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: The primary objective of the study is to characterize and measure the impact of major surgery on the kinetics of endothelial function during the perioperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery, Thoracic Surgery
- What is being tested?
- Endothelial Function Test
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Nov 2010
- Phase
- Observational
- 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
Study population: Study participants scheduled to have major abdominal or thoracic surgery.
Who may be able to join
- Male and female patients 18 years and older
- Patient scheduled for major abdominal (intraperitoneal) or thoracic (intrapleural) surgery
Who cannot join
- Patients under age of 18. They will be excluded because it is less likely for this patient population to face endothelial dysfunction secondary to vascular sclerosis.
- Patients unwilling to sign an informed consent.
- Any patient whose condition is deemed unsatisfactory for surgery after the preanesthetic evaluation.
- Patients with lymphedema in the arm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterizing the Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring: an Observational Study of a Surrogate Marker of Endothelial Function
Primary Objective:
The primary objective of the study is to characterize and measure the impact of major surgery on the kinetics of endothelial function during the perioperative period. Reactive hyperemia, characterized by Digital Thermal Monitoring (DTM), will be utilized to characterize this during the perioperative period in patients undergoing major abdominal or thoracic surgery. This will attempt to characterize the relationship between impaired endothelial function, the extent of surgical insult, and the risk for adverse postoperative outcome.
Read more
Secondary Objectives:
Secondary objectives of this study will evaluate the following:
- The incidence of major complications in correlation to reduced preoperative reactive hyperemia
- The incidence of major complications in correlation to reduced postoperative reactive hyperemia (calculated as absolute value and as the change from baseline [delta]).
- It is anticipated that two factors (namely, preoperative cardiovascular risk and the extent of the intraoperative inflammatory response) will predominantly contribute to the impaired microcirculatory/hyperemic/endothelial function and should therefore be accounted for in this study. The correlation between impaired reactive hyperemia and these two contributory factors will be evaluated.
- Preoperative cardiovascular risk will be assessed using risk scoring systems that attempt to infer patient risk according to preoperative co-morbidities, namely The ASA Physical Status Classification System24, The Lee Modified Cardiac Risk Index,25 and The University of Texas M. D. Anderson Cancer Center Modifiers to the Lee Modified Cardiac Risk Index (an unvalidated scoring system that considers factors unique to the cancer surgical population), and The Metabolic Syndrome. The latter represents a larger at-risk patient population who has yet to develop symptomatic cardiac lesions (and therefore will not be identified by the Lee modified Cardiac Risk Index).
- Intraoperative inflammatory response will be assessed using quantitative assays for C-RP, and cytokines.
- Multivariate analysis will analyze for intraoperative perturbations-including hemodynamic (heart rate, blood pressure), temperature, and fluid shifts (blood loss, transfusions.
Read the detailed description
The Endothelial Function Test:
To perform an endothelial function test, your temperature will be taken using your fingertip on both hands using the Vendy's-DTM machine. The Vendy's-DTM machine uses small sleeves that fit over your fingertips to take your temperature. After your temperature is taken, your right arm will be placed in a standard blood pressure cuff. After the cuff is inflated for 2 minutes, your temperature will be taken again from the same fingertip. The difference of temperatures before and after inflation may be able to predict endothelial complications, such as lung function, heart failure and heart attack.
This test will be performed within 20 days before your scheduled surgery, when surgery begins (at the time of incision), every hour during surgery and then 1, 2, 3, and 5 days after your surgery.
Follow-up:
You will be called to collect information about your overall health at 30 days and 1 year after surgery. The phone call will last about 30 minutes.
Length of Study:
You will be off study after the second phone call.
This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Abdominal Surgery, Thoracic Surgery
- Being tested
- Endothelial Function Test
- Keywords
- Endothelial Function, Abdominal Surgery, Thoracic Surgery, Vendy's-DTM Machine, Digital Thermal Monitoring, DTM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelial Function TestOther
Endothelial function tests performed within 20 days before surgery, when surgery begins (at the time of incision), every hour during surgery and then 1, 2, 3, and 5 days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Endothelial Function Test | Patients scheduled to have major abdominal or thoracic surgery. Receives: Other: Endothelial Function Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of each post baseline temperature rebound (TR) measure to baseline
Measured: Tests performed within 20 days before scheduled surgery, when surgery begins (at the time of incision), every hour during surgery and then 1, 2, 3, and 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vijaya Gottumukkala, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683150
- Sponsor's protocol ID
- 2008-0126
- Status last verified
- Jul 2012
- First submitted
- 21 May 2008
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring: an Observational Study of a Surrogate Marker of Endothelial Function
- ClinicalTrials.gov ID
- NCT00683150
- Acronym / sponsor ID
- 2008-0126
- Conditions
- Abdominal Surgery, Thoracic Surgery
- Keywords
- Endothelial Function, Abdominal Surgery, Thoracic Surgery, Vendy's-DTM Machine, Digital Thermal Monitoring, DTM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 23 May 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.
Primary Objective:
The primary objective of the study is to characterize and measure the impact of major surgery on the kinetics of endothelial function during the perioperative period. Reactive hyperemia, characterized by Digital Thermal Monitoring (DTM), will be utilized to characterize this during the perioperative period in patients undergoing major abdominal or thoracic surgery. This will attempt to characterize the relationship between impaired endothelial function, the extent of surgical insult, and the risk for adverse postoperative outcome.
Secondary Objectives:
Secondary objectives of this study will evaluate the following:
- The incidence of major complications in correlation to reduced preoperative reactive hyperemia
- The incidence of major complications in correlation to reduced postoperative reactive hyperemia (calculated as absolute value and as the change from baseline [delta]).
- It is anticipated that two factors (namely, preoperative cardiovascular risk and the extent of the intraoperative inflammatory response) will predominantly contribute to the impaired microcirculatory/hyperemic/endothelial function and should therefore be accounted for in this study. The correlation between impaired reactive hyperemia and these two contributory factors will be evaluated.
- Preoperative cardiovascular risk will be assessed using risk scoring systems that attempt to infer patient risk according to preoperative co-morbidities, namely The ASA Physical Status Classification System24, The Lee Modified Cardiac Risk Index,25 and The University of Texas M. D. Anderson Cancer Center Modifiers to the Lee Modified Cardiac Risk Index (an unvalidated scoring system that considers factors unique to the cancer surgical population), and The Metabolic Syndrome. The latter represents a larger at-risk patient population who has yet to develop symptomatic cardiac lesions (and therefore will not be identified by the Lee modified Cardiac Risk Index).
- Intraoperative inflammatory response will be assessed using quantitative assays for C-RP, and cytokines.
- Multivariate analysis will analyze for intraoperative perturbations-including hemodynamic (heart rate, blood pressure), temperature, and fluid shifts (blood loss, transfusions.
Detailed description
The Endothelial Function Test:
To perform an endothelial function test, your temperature will be taken using your fingertip on both hands using the Vendy's-DTM machine. The Vendy's-DTM machine uses small sleeves that fit over your fingertips to take your temperature. After your temperature is taken, your right arm will be placed in a standard blood pressure cuff. After the cuff is inflated for 2 minutes, your temperature will be taken again from the same fingertip. The difference of temperatures before and after inflation may be able to predict endothelial complications, such as lung function, heart failure and heart attack.
This test will be performed within 20 days before your scheduled surgery, when surgery begins (at the time of incision), every hour during surgery and then 1, 2, 3, and 5 days after your surgery.
Follow-up:
You will be called to collect information about your overall health at 30 days and 1 year after surgery. The phone call will last about 30 minutes.
Length of Study:
You will be off study after the second phone call.
This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endothelial Function Test | – | Other: Endothelial Function TestPatients scheduled to have major abdominal or thoracic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants scheduled to have major abdominal or thoracic surgery.
Key inclusion criteria (2 listed)
- Male and female patients 18 years and older
- Patient scheduled for major abdominal (intraperitoneal) or thoracic (intrapleural) surgery
Key exclusion criteria (4 listed)
- Patients under age of 18. They will be excluded because it is less likely for this patient population to face endothelial dysfunction secondary to vascular sclerosis.
- Patients unwilling to sign an informed consent.
- Any patient whose condition is deemed unsatisfactory for surgery after the preanesthetic evaluation.
- Patients with lymphedema in the arm.
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 |
|---|---|---|
| Endothelial Function TestEndothelial function tests performed within 20 days before surgery, when surgery begins (at the time of incision), every hour during surgery and then 1, 2, 3, and 5 days after surgery. | Other | Endothelial Function Test |
Primary outcome
Ratio of each post baseline temperature rebound (TR) measure to baseline
Time frame: Tests performed within 20 days before scheduled surgery, when surgery begins (at the time of incision), every hour during surgery and then 1, 2, 3, and 5 days after surgery
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 31 Jul 2012.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Vijaya Gottumukkala, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Surgery and Thoracic Surgery, run by M.D. Anderson Cancer Center at 1 site 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 2 inclusion and 4 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 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Ratio of each post baseline temperature rebound (TR) measure to baseline (time frame: Tests performed within 20 days before scheduled surgery, when surgery begins (at the time of incision), every hour during surgery and then 1, 2, 3, and 5 days after surgery). 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 31 Jul 2012.