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

May 6, 2008
May 7, 2008
April 3, 2015
May 4, 2015
January 19, 2018
April 2008
September 2012   (Final data collection date for primary outcome measure)
Hospital Acquired Pneumonia [ Time Frame: 30 days postoperative ]
Pneumonia diagnosed during hospitalization
Hospital Acquired Pneumonia [ Time Frame: 30 days postoperative ]
Complete list of historical versions of study NCT00673712 on Archive Site
  • Surgical Site Infection [ Time Frame: 30 days postoperative ]
    surgical site infection diagnosed within 30 days post surgery
  • Hospital Length of Stay [ Time Frame: primary admission ]
    time (days) from date of admission to discharge
  • Surgical Site Infection [ Time Frame: 30 days postoperative ]
  • Hospital Length of Stay [ Time Frame: primary admission ]
Not Provided
Not Provided
Multicenter Infection Surveillance Study Following Open Heart Surgery
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Surgery
  • Pneumonia
  • Surgical Site Infection
  • Device: Continuous Sternal Block
    Elastomeric Pump for Continuous Infusion of Local Anesthetic
    Other Names:
    • ON-Q
    • PainBuster
  • Drug: Opioid based analgesia

    Opioid Analgesic agents delivered by:

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

    Other Name: PCA
  • Experimental: Continuous Sternal Block
    Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
    Intervention: Device: Continuous Sternal Block
  • Active Comparator: Opioid based analgesia
    Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics
    Intervention: Drug: Opioid based analgesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Halyard Health
Halyard Health
Not Provided
Principal Investigator: Ali Husain, MD The Cleveland Clinic
Halyard Health
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP