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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of California, Davis
Sponsor:
Information provided by (Responsible Party):
Hong Liu, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01683448
First received: September 7, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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
Patient Outcomes After Cardiac Surgery.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Effect of Perioperative Medications on the Outcomes of Patients Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Mortality [ Time Frame: In hospital, 30 day, 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1
Study Start Date: February 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cardiac surgical patients

Criteria

Inclusion Criteria:

  • All cardiac surgical patients

Exclusion Criteria:

  • Non cardiac surgery
  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: NCT01683448

Contacts
Contact: Hong Liu, M.D. 916-734-5394 hualiu@ucdavis.edu
Contact: Carolyn Murdock 916-734-5394 carolyn.murdock@ucdmc.ucdavis.edu

Locations
United States, California
UC Davis, Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Hong Liu, M.D.    916-734-5394    hualiu@ucdavis.edu   
Contact: Carolyn Murdock    916-734-5394    carolyn.murdock@ucdmc.ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Hong Liu, M.D. UC Davis, Department of Anesthesiology and Pain Medicine
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hong Liu, MD, Associate Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT01683448     History of Changes
Other Study ID Numbers: 298807
Study First Received: September 7, 2012
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Davis:
Perioperative medications
cardiac surgery
outcomes

ClinicalTrials.gov processed this record on October 23, 2014