Multicenter Infection Surveillance Study Following Open Heart Surgery
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Surgery Pneumonia Surgical Site Infection |
Device: Continuous Sternal Block Drug: Opioid based analgesia |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures |
- hospital acquired pneumonia [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
- surgical site infection [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
- hospital length of stay [ Time Frame: primary admission ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1300 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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
|
Detailed Description:
Nosocomial infections are recognized as an important cause of increased patient mor-bidity and mortality. The reported prevalence for nosocomial infections most com-monly 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 develop-ment 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 antibiot-ics 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 hospitaliza-tion, development of multiorgan dysfunction, and increased hospital mortality. Nosocomial Pneumonia (NP) is in fact the leading cause of mortality due to hospital-acquired infec-tions.22 Patients with 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| Principal Investigator: | Ali Husain, MD | The Cleveland Clinic |
More Information
No publications provided
| Responsible Party: | I-Flow |
| ClinicalTrials.gov Identifier: | NCT00673712 History of Changes |
| Other Study ID Numbers: | iflocv2008 |
| Study First Received: | May 6, 2008 |
| Last Updated: | August 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by I-Flow:
|
Coronary Artery Bypass Graft Surgery Pneumonia Surgical Site Infection |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Anesthetics, Local Analgesics, Opioid Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics |
ClinicalTrials.gov processed this record on May 23, 2013