Endothelial Dysfunction As A Predictor Of Perioperative Outcome In Major Thoracic Surgery - An Observational Study
18 Years
N/A
Both
Endothelial Dysfunction
Trial Information
Endothelial Dysfunction As A Predictor Of Perioperative Outcome In Major Thoracic Surgery - An Observational Study
A small group of patients (about 12 out of every 100) are at risk of developing
complications, for example lung infection, after their surgery. Researchers do not always
know which patient is at risk or the reason why some patients develop these complications.
Your participation in this study may help researchers to understand who is at risk and also
the mechanism of some of the complications.
The inner layer of cells of blood vessels are called endothelial cells. This layer of cells
plays a vital role in the normal function of blood vessels, including blood clotting and
inflammation. Certain conditions, such as aging, smoking, high cholesterol, and some
chemotherapies cause these cells to not function properly. Researchers can test whether
these cells function properly by doing two simple tests - one is a blood test and the other
uses ultrasound and temperature probes on the finger to look at the ability of arm blood
vessels to dilate (expand).
The way your cells function will be tested within a month before your scheduled chemotherapy
/ radiation (if applicable), and again within a month before your major chest surgery. This
will be done on those patients with surgery planned or scheduled.
About 2 tablespoons of blood will be drawn to measure the number of circulating blood cells
that become endothelial cells.
During your scheduled surgery, the researcher will also collect just over a teaspoon of
blood at the beginning of the surgery for an additional endothelial risk assessment and a
small sample of lung tissue, if available. Tissue removed during long surgery is usually
thrown away if it is not needed for diagnosis and or treatment purposes. The lung tissue
sample collected for this research study will only be taken from lung tissue that is to be
discarded. The lung tissue will be used to determine the amount of a naturally occurring
substance thought to play a role in recruiting blood cells to repair injured lung tissue.
Blood samples (about 2 tablespoons) will also be collected after exercise, during your
surgery, 24 hours after your surgery, and at 5 days after surgery or the time you discharge
from the hospital (which ever is shorter). These blood samples will also be collected at
your routinely schedule post operative clinic visits at 1 month, 6 months, and 1 year after
surgery. The samples will be used to determine the amount of endothelial cells in the blood
stream.
For healthy volunteers, blood samples (about 2 tablespoons) will be collected at baseline
(prior to exercising), 15-30 minutes past peak exercise, 3 hours past peak exercise and at
24 hours past past peak exercise.
Data will be collected on you for 30 days after your surgery, and during the 1 year
follow-up. These data will then be matched with the amount of cell function as measured
before surgery to see if these tests may be used to help predict which patients are at
increased risk for complications. No other measurements will be done and this study will
not change your surgical procedure or lengthen your hospital stay.
This is an investigational study. About 90 patients will take part in this study. All
will be enrolled at The University of Texas (UT) MD Anderson Cancer Center (MDACC).
Inclusion Criteria:
1. Patients scheduled for major thoracic surgery (lobectomy, pneumonectomy,
esophagectomy).
2. Patients 18 years of age or older.
3. Patients who have signed the consent form to participate in the study.
4. Patients must have been evaluated in the Preanesthesia Clinic or by a staff
Anesthesiologist preoperatively.
5. All laboratory and diagnostic evaluations required or used to evaluate the patient in
the Preanesthesia Clinic must be completed. All patients must be approved for surgery
by the standards of the Preanesthesia Clinic.
Exclusion Criteria:
1. Refusal to participate in the study.
2. Patient is under age 18.
3. Patient is unwilling to sign consent.
4. Patient is unable to exercise (bedridden or wheel chair bound).
5. Patient is enrolled in another study deemed by the investigator to affect oxygen
metabolic efficiency and not presently the standard of care at MDACC.
6. Any patient whose condition is deemed unsatisfactory for surgery after the
preanesthetic evaluation.
7. Surgery canceled for any reason. The patient may reenter the study if surgery is
rescheduled.
8. Patient has had a myocardial infarction within 3 months of visiting the Preanesthesia
Clinic or presents with new or unstable angina.
9. Patient has a history of cerebrovascular accident or transient ischemic attacks
within 3 months of visiting the Preanesthesia Clinic.
10. Patient has a history of pulmonary embolic event within 3 months of visiting the
Preanesthesia Clinic.
11. Patient known to have acute or chronic deep vein thrombosis.
12. Pregnant patients.
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Number of Patient Major Pulmonary Events (MPE)
Outcome Time Frame:
Baseline (entry in study) to end of study (estimated 1 year post-operative)
Safety Issue:
No
Principal Investigator
Reza-John Mehran, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2003-0434
NCT ID:
NCT00384683
Start Date:
March 2006
Completion Date:
May 2012
Related Keywords:
- Endothelial Dysfunction
- Endothelial Dysfunction
- Endothelial Cells
- Perioperative Outcome
- Blood Sample
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
