Status:
COMPLETED
Multicenter Infection Surveillance Study Following Open Heart Surgery
Lead Sponsor:
Halyard Health
Conditions:
Surgery
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infectio...
Detailed Description
Nosocomial infections are recognized as an important cause of increased patient morbidity and mortality. The reported prevalence for nosocomial infections most commonly ranges from 5 to 20%, but can b...
Eligibility Criteria
Inclusion
- Men and women, \>18 years of age;
- Scheduled for elective cardiac surgical procedure, including coronary revasculari-zation or valve surgery;
- Provision of informed consent
Exclusion
- Patients with a prior allergic reaction or dependency to morphine, Demerol, Di-laudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);
- Cardiac transplant patients
- Inability to perform follow-up assessments;
- Pre-existing infection (pneumonia or surgical site)
- Repeat of primary surgery
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
647 Patients enrolled
Trial Details
Trial ID
NCT00673712
Start Date
April 1 2008
End Date
September 1 2012
Last Update
January 19 2018
Active Locations (8)
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1
St. Vincents East
Birmingham, Alabama, United States, 35235
2
Christianna Care Health System
Newark, Delaware, United States, 19713
3
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40506
4
Ochsner
New Orleans, Louisiana, United States, 70121