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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00683150 |
Primary Objective:
1. 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:
1. To evaluate the following:
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).
Condition | Intervention |
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Abdominal Surgery Thoracic Surgery |
Other: Endothelial Function Test |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Characterizing the Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring: an Observational Study of a Surrogate Marker of Endothelial Function |
Estimated Enrollment: | 60 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patients scheduled to have major abdominal or thoracic surgery.
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Other: Endothelial Function Test
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. |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Study participants scheduled to have major abdominal or thoracic surgery.
Inclusion Criteria:
Exclusion Criteria:
Contact: Vijaya Gottumukkala, MD | 713-792-6911 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Vijaya Gottumukkala, MD |
Principal Investigator: | Vijaya Gottumukkala, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Vijaya Gottumukkala, MD/Associate Professor ) |
Study ID Numbers: | 2008-0126 |
Study First Received: | May 21, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00683150 History of Changes |
Health Authority: | United States: Institutional Review Board |
Endothelial Function Abdominal Surgery Thoracic Surgery |
Vendy's-DTM Machine Digital Thermal Monitoring DTM |
Hyperemia Vascular Diseases |
Hyperemia Vascular Diseases Cardiovascular Diseases |