Multicenter Infection Surveillance Study Following Open Heart Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00673712
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : May 4, 2015
Last Update Posted : January 19, 2018
Information provided by (Responsible Party):
Halyard Health

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.

Condition or disease Intervention/treatment Phase
Surgery Pneumonia Surgical Site Infection Device: Continuous Sternal Block Drug: Opioid based analgesia Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 647 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures
Study Start Date : April 2008
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Continuous Sternal Block
Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
Device: Continuous Sternal Block
Elastomeric Pump for Continuous Infusion of Local Anesthetic
Other Names:
  • ON-Q
  • PainBuster
Active Comparator: Opioid based analgesia
Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics
Drug: Opioid based analgesia

Opioid Analgesic agents delivered by:

PCA on demand mode IV injections PRN IM injections PRN Oral PRN

Other Name: PCA

Primary Outcome Measures :
  1. Hospital Acquired Pneumonia [ Time Frame: 30 days postoperative ]
    Pneumonia diagnosed during hospitalization

Secondary Outcome Measures :
  1. Surgical Site Infection [ Time Frame: 30 days postoperative ]
    surgical site infection diagnosed within 30 days post surgery

  2. Hospital Length of Stay [ Time Frame: primary admission ]
    time (days) from date of admission to discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00673712

United States, Alabama
St. Vincents East
Birmingham, Alabama, United States, 35235
United States, Delaware
Christianna Care Health System
Newark, Delaware, United States, 19713
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40506
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, North Carolina
Cape Fear valley Hospital
Fayetteville, North Carolina, United States, 28304
United States, Ohio
Medcentral Hospital
Mansfield, Ohio, United States, 44903
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
United States, Wisconsin
Waukesha Medical Center
West Allis, Wisconsin, United States, 53227
Sponsors and Collaborators
Halyard Health
Principal Investigator: Ali Husain, MD The Cleveland Clinic

Responsible Party: Halyard Health Identifier: NCT00673712     History of Changes
Other Study ID Numbers: iflocv2008
First Posted: May 7, 2008    Key Record Dates
Results First Posted: May 4, 2015
Last Update Posted: January 19, 2018
Last Verified: April 2015

Keywords provided by Halyard Health:
Coronary Artery Bypass Graft Surgery
Surgical Site Infection

Additional relevant MeSH terms:
Communicable Diseases
Surgical Wound Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Wound Infection
Postoperative Complications
Pathologic Processes
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents