Clinical trial NCT00673712: Multicenter Infection Surveillance Study Following Open Heart Surgery
Official title: Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Pneumonia
Surgical Site Infection
Keywords: Coronary Artery Bypass Graft Surgery
Pneumonia
Surgical Site Infection
Lead sponsor: Halyard Health
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 647
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 infection in cardiac surgery patients; and (2) to evaluate the relationship between hospital-acquired pneumonia and surgical infection and patient outcomes, including length of hospital stay.

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 be significantly greater among patients requiring intensive care. The most common sites of hospital acquired infection include the lung, urinary tract, surgical wounds, and the bloodstream. Patients undergoing cardiac surgery appear to be at increased risk for the development of nosocomial infections due to the presence of multiple surgical wounds (chest and lower extremity incisions), frequent postoperative utilization of invasive devices (i.e. central venous catheters, chest drains, intra-aortic balloon counter pulsation, pulmonary artery catheter), and the common use of prophylactic or empiric antibiotics in the perioperative period. In the cardiac surgical postoperative period, nosocomial infections have been found to be associated with prolonged length of stay (LOS) in the ICU and total hospitalization, development of multiorgan dysfunction, and increased hospital mortality. Nosocomial Pneumonia (NP) is in fact the leading cause of mortality due to hospital-acquired infections. Patients with Ventilator Associated Pneumonia (VAP) have been found in various studies to have significantly higher mortality rates than those without VAP, with ranges of 20.2-45.5% and 8.5-32.2%, respectively. Strategies that both reduce postoperative pain and sedation have the potential to reduce postoperative pneumonia by allowing earlier extubation and more effective pulmonary toilet post-extubation. Non-opioid pain management has the potential to reduce NP rates because of superior pain management, as well as the reduction in opioids required, and the concomitant avoidance of opioid side effects. The clinical and financial consequences of NP justify aggressively pursuing strategies aimed at prevention. Specifically, these strategies are targeted at reducing the incidence of NP by addressing the modifiable risk factors including prolonged endotracheal intubation and ventilator support, sedation, and long hospital LOS.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Hospital Acquired Pneumonia
timeFrame: 30 days postoperative
Secondary outcomes:
measure: Surgical Site Infection
timeFrame: 30 days postoperative
measure: Hospital Length of Stay
timeFrame: primary admission
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: St. Vincents East
state: Alabama
city: Newark
country: United States
facility: Christianna Care Health System
state: Delaware
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner
state: Louisiana
city: Fayetteville
country: United States
facility: Cape Fear valley Hospital
state: North Carolina
city: Mansfield
country: United States
facility: Medcentral Hospital
state: Ohio
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: West Allis
country: United States
facility: Waukesha Medical Center
state: Wisconsin
Study officials:
affiliation: The Cleveland Clinic
name: Ali Husain, MD
role: PRINCIPAL_INVESTIGATOR
References: