Multicenter Infection Surveillance Study Following Open Heart Surgery

• ClinicalTrials.gov Identifier: NCT00673712
• Recruitment Status: Completed
• First Posted: May 7, 2008
• Results First Posted: May 4, 2015
• Last Update Posted: January 19, 2018
• Sponsor: Halyard Health
• Information provided by (Responsible Party): Halyard Health

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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

Ochsner

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

Investigators

• Principal Investigator: Ali Husain, MD; The Cleveland Clinic

More Information

• Responsible Party: Halyard Health
• ClinicalTrials.gov Identifier: NCT00673712
• Other Study ID Numbers: iflocv2008
• First Posted: May 7, 2008
• 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; Pneumonia; Surgical Site Infection

Additional relevant MeSH terms:

Infections; Communicable Diseases; Pneumonia; Surgical Wound Infection; Disease Attributes; Pathologic Processes; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Wound Infection; Postoperative Complications; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents