Multicenter Infection Surveillance Study Following Open Heart Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures

Conditions
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Surgery, Pneumonia, Surgical Site Infection

Intervention / Treatment
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* Device: Continuous Sternal Block
* Drug: Opioid based analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Sternal Block<br>Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system | Device: Continuous Sternal Block<br>* Elastomeric Pump for Continuous Infusion of Local Anesthetic<br>* Other names: PainBuster;|
| Active Comparator: Opioid based analgesia<br>Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics | Drug: Opioid based analgesia<br>* Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN<br>* Other names: PCA;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Graft Surgery, Pneumonia, Surgical Site Infection