Multicenter Infection Surveillance Study Following Open Heart Surgery

Phase 4

Completed

Conditions: Surgery
Pneumonia
Surgical Site Infection

Interventions: Device: Continuous Sternal Block
Drug: Opioid based analgesia

Registration Number: NCT00673712

Lead Sponsor: Halyard Health

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 647

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Sternal Block	Continuous Sternal Block	Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
Opioid based analgesia	Opioid based analgesia	Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics

Primary Outcome Measures

Name	Time	Method
Hospital Acquired Pneumonia	30 days postoperative	Pneumonia diagnosed during hospitalization

Secondary Outcome Measures

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

Trial Locations

Locations (8): Christianna Care Health System
🇺🇸
Newark, Delaware, United States
Waukesha Medical Center
🇺🇸
West Allis, Wisconsin, United States
Ochsner
🇺🇸
New Orleans, Louisiana, United States
St. Vincents East
🇺🇸
Birmingham, Alabama, United States
University of Kentucky Medical Center
🇺🇸
Lexington, Kentucky, United States
Cape Fear valley Hospital
🇺🇸
Fayetteville, North Carolina, United States
Medcentral Hospital
🇺🇸
Mansfield, Ohio, United States
Methodist Hospital
🇺🇸
Houston, Texas, United States