Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01683448 |
| Other study ID # |
298807 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 2010 |
| Est. completion date |
February 2015 |
Study information
| Verified date |
December 2020 |
| Source |
University of California, Davis |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study will be a retrospective study. The patient data from the electronic medical
records and existing database will be collected and analyzed. Primary endpoints will be
postoperative mortality (within 30 days) and overall complications and length of hospital
stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia,
ischemia, stroke, neurological complications, length of ICU stay, re-admission rate,
infections, pulmonary complications, length of intubation time, length of ventilation time,
and acute renal failure.
Description:
Each year about 694,000 Americans have open-heart surgery including valve repairs, valve
replacements, heart transplants, and coronary artery bypass graft (CABG) surgery [1]. The
reported incidence of perioperative complications in these cardiac surgery patients is 4.5%
while the prevalence varied from1.6% to 14.1% [2,3]. As the population ages, increased
numbers of elderly patients with more advanced cardiac diseases and comorbidities are being
referred for cardiac surgery. For these patients, postoperative cardiovascular complications
(cardiac death, myocardial infarction (MI), ischemia, congestive heart failure (CHF),
arrhythmia, stroke, and acute renal failure (ARF)) represent the major postoperative
complications [4-6]. These complications translate into increased mortality, prolonged
hospital stay and estimated costs exceeding $20 billion annually [7].
These events may be triggered by surgical stress responses that result in increased plasma
levels of norepinephrine and epinephrine [8], myocardial oxygen supply demand imbalance, and
plaque rupture [9].
Beta-blockers, ACE inhibitors, alfa2-agonists, Aspirin, statins, nitrates, anti-platelet
medications and anticoagulation medications have been widely used in patients with coronary
artery disease, hypertension and other heart diseases. Beta-blockers, ACE inhibitors and
Aspirin statins have also been shown to have a positive impact on the outcomes of surgical
and non-surgical treatments [10-11]. However, there are other studies which were unable to
demonstrate the positive results of these medications on post-operative outcomes.
Based on the previous studies referenced above, we propose that the use of perioperative
medications (Betablockers, ACE inhibitors, alfa2-agonists, Aspirin, statins, nitrates,
anti-platelet medications, and anticoagulation medications) may provide cardiac protection
for cardiac surgical patients. The specific aim of this study is to retrospectively
investigate whether perioperative medication use is associated with decreases in the
incidence of postoperative cardiovascular complications in patients undergoing elective
cardiac surgery.
This study will be a retrospective study. The patient data from the electronic medical
records and existing database will be collected and analyzed. Primary endpoints will be
postoperative mortality (within 30 days) and overall complications and length of hospital
stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia,
ischemia, stroke, neurological complications, length of ICU stay, re-admission rate,
infections, pulmonary complications, length of intubation time, length of ventilation time,
and acute renal failure.
