Multicenter Infection Surveillance Study Following Open Heart Surgery

NCT ID: NCT00673712

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 647 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-09-30

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.

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.

Conditions

Surgery; Pneumonia; Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous Sternal Block

Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system

Group Type: EXPERIMENTAL

Continuous Sternal Block

Intervention Type: DEVICE

Elastomeric Pump for Continuous Infusion of Local Anesthetic

Opioid based analgesia

Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics

Group Type: ACTIVE_COMPARATOR

Opioid based analgesia

Intervention Type: DRUG

Opioid Analgesic agents delivered by:

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

Interventions

Continuous Sternal Block

Elastomeric Pump for Continuous Infusion of Local Anesthetic

Intervention Type: DEVICE

Opioid based analgesia

Opioid Analgesic agents delivered by:

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

Intervention Type: DRUG

Other Intervention Names

ON-Q; PainBuster; PCA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Halyard Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Husain, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

St. Vincents East

Birmingham, Alabama, United States

Christianna Care Health System

Newark, Delaware, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Ochsner

New Orleans, Louisiana, United States

Cape Fear valley Hospital

Fayetteville, North Carolina, United States

Medcentral Hospital

Mansfield, Ohio, United States

Methodist Hospital

Houston, Texas, United States

Waukesha Medical Center

West Allis, Wisconsin, United States

Countries

United States

Other Identifiers

iflocv2008

Identifier Type: -

Identifier Source: org_study_id