Multicenter Infection Surveillance Study Following Open Heart Surgery



Status:Completed
Conditions:Pneumonia, Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:1/21/2018
Start Date:April 2008
End Date:September 2012

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Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures

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.

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.

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
We found this trial at
8
sites
200 Hygeia Drive
Newark, Delaware 19713
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Newark, DE
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740 South Limestone Street
Lexington, Kentucky 40536
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Lexington, KY
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Birmingham, Alabama 35235
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Birmingham, AL
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1638 Owen Drive
Fayetteville, North Carolina 28304
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Fayetteville, NC
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Houston, Texas 77030
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Houston, TX
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Mansfield, Ohio 44903
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Mansfield, OH
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New Orleans, Louisiana 70121
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from
New Orleans, LA
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8901 West Lincoln Avenue
West Allis, Wisconsin 53227
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from
West Allis, WI
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