Multicenter Infection Surveillance Study Following Open Heart Surgery

This study has suspended participant recruitment.
(PENDING INTERIM ANALYSIS)
Sponsor:
Information provided by (Responsible Party):
I-Flow
ClinicalTrials.gov Identifier:
NCT00673712
First received: May 6, 2008
Last updated: August 31, 2012
Last verified: August 2012

May 6, 2008
August 31, 2012
April 2008
September 2012   (final data collection date for primary outcome measure)
hospital acquired pneumonia [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00673712 on ClinicalTrials.gov Archive Site
  • surgical site infection [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
  • hospital length of stay [ Time Frame: primary admission ] [ Designated as safety issue: No ]
Same as current
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 mor-bidity and mortality. The reported prevalence for nosocomial infections most com-monly 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 develop-ment 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 antibiot-ics 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 hospitaliza-tion, development of multiorgan dysfunction, and increased hospital mortality. Nosocomial Pneumonia (NP) is in fact the leading cause of mortality due to hospital-acquired infec-tions.22 Patients with 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
1300
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00673712
iflocv2008
No
I-Flow
I-Flow
Not Provided
Principal Investigator: Ali Husain, MD The Cleveland Clinic
I-Flow
August 2012

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