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The Effect of Perioperative Medications on the Outcomes of Patients Undergoing Cardiac Surgery

Sponsor
University of California, Davis (Other)
Overall Status
Completed
CT.gov ID
NCT01683448
Collaborator
(none)
1
Enrollment
1
Location
60
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Effect of Perioperative Medications on the Outcomes of Patients Undergoing Cardiac Surgery
    Actual Study Start Date :
    Feb 1, 2010
    Actual Primary Completion Date :
    Feb 1, 2015
    Actual Study Completion Date :
    Feb 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. hemodynamic changes [In hospital]

      blood pressure and heart rare

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All cardiac surgical patients
    Exclusion Criteria:
    • Non cardiac surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC Davis, Medical Center Sacramento California United States 95817

    Sponsors and Collaborators

    • University of California, Davis

    Investigators

    • Principal Investigator: Hong Liu, M.D., UC Davis, Department of Anesthesiology and Pain Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, Davis
    ClinicalTrials.gov Identifier:
    NCT01683448
    Other Study ID Numbers:
    • 298807
    First Posted:
    Sep 11, 2012
    Last Update Posted:
    Dec 3, 2020
    Last Verified:
    Dec 1, 2020
    Keywords provided by University of California, Davis
    Perioperative medications
    cardiac surgery
    outcomes
    Additional relevant MeSH terms:
    Heart Diseases

    Study Results

    No Results Posted as of Dec 3, 2020