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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Surgery; Surgical Site Infection
• Intervention / Treatment: Device: Continuous Sternal Block; Drug: Opioid based analgesia

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
• Enrollment (Actual): 647
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • St. Vincents East
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christianna Care Health System
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Cape Fear valley Hospital
  • Ohio
    • Mansfield, Ohio, United States, 44903
      • Medcentral Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Methodist Hospital
  • Wisconsin
    • West Allis, Wisconsin, United States, 53227
      • Waukesha Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Acquired Pneumonia	Pneumonia diagnosed during hospitalization	30 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Infection	surgical site infection diagnosed within 30 days post surgery	30 days postoperative
Hospital Length of Stay	time (days) from date of admission to discharge	primary admission

Collaborators and Investigators

• Sponsor: Halyard Health
• Investigators: Principal Investigator: Ali Husain, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: May 6, 2008
• First Submitted That Met QC Criteria: May 6, 2008
• First Posted (Estimate): May 7, 2008

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Pneumonia; Surgical Site Infection; Coronary Artery Bypass Graft Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Pneumonia; Surgical Wound Infection; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: iflocv2008