Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring

NCT00683150 | Completed

• 1 other identifier: 2008-0126
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.
• 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.

Conditions

Abdominal Surgery; Thoracic Surgery

Keywords

Endothelial Function; Abdominal Surgery; Thoracic Surgery; Vendy's-DTM Machine; Digital Thermal Monitoring; DTM

Outcome Measures

Primary Outcomes (1)

• Ratio of each post baseline temperature rebound (TR) measure to baseline

  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

Study Arms (1)

Endothelial Function Test

Patients scheduled to have major abdominal or thoracic surgery.

Other: Endothelial Function Test

Interventions

Endothelial Function Test OTHER

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.

Endothelial Function Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants scheduled to have major abdominal or thoracic surgery.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

Study Officials

• Vijaya Gottumukkala, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

US (1)