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Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00683150
First received: May 21, 2008
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 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.

Condition Intervention
Abdominal Surgery
Thoracic Surgery
Other: Endothelial Function Test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: 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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: May 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Endothelial Function Test
Patients scheduled to have major abdominal or thoracic surgery.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study participants scheduled to have major abdominal or thoracic surgery.

Criteria

Inclusion Criteria:

  1. Male and female patients 18 years and older
  2. Patient scheduled for major abdominal (intraperitoneal) or thoracic (intrapleural) surgery

Exclusion Criteria:

  1. 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.
  2. Patients unwilling to sign an informed consent.
  3. Any patient whose condition is deemed unsatisfactory for surgery after the preanesthetic evaluation.
  4. Patients with lymphedema in the arm.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683150

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Vijaya Gottumukkala, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00683150     History of Changes
Other Study ID Numbers: 2008-0126
Study First Received: May 21, 2008
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Endothelial Function
Abdominal Surgery
Thoracic Surgery
Vendy's-DTM Machine
Digital Thermal Monitoring
DTM

ClinicalTrials.gov processed this record on November 25, 2014