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NCT00683150 · ClinicalTrials.gov registry record
Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring
A clinical trial, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- 59
- Enrollment target
NCT00683150: Completed study, sponsored by M.D. Anderson Cancer Center.
NCT00683150 is a clinical trial that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00683150 has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- 59 participants
- Enrollment target
Study 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. 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. 1. 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). 2. Intraoperative
Interventions
- OTHER Endothelial Function Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00683150
The ClinicalTrials.gov registry entry for NCT00683150 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Endothelial Function Test is the first listed.
NCT00683150 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00683150 about?
NCT00683150 is a clinical study titled "Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring". 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 duri...
What is the current status of trial NCT00683150?
This trial is currently completed. The enrollment target is 59 participants. The study started on 2008-05. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00683150?
The interventions under investigation include: Endothelial Function Test (OTHER).
Who is sponsoring clinical trial NCT00683150?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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