Multicenter Infection Surveillance Study Following Open Heart Surgery

Surgery Clinical Trial

Official title:

Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673712
• Other study ID #: iflocv2008
• Status: Completed
• Phase: Phase 4
• First received: May 6, 2008
• Last updated: December 18, 2017
• Start date: April 2008
• Est. completion date: September 2012

Study information

• Verified date: April 2015
• Source: Halyard Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 647
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pneumonia
• Surgery
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Device:
• Continuous Sternal Block
Elastomeric Pump for Continuous Infusion of Local Anesthetic

Drug:
• Opioid based analgesia
Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN

Locations

Country	Name	City	State
United States	St. Vincents East	Birmingham	Alabama
United States	Cape Fear valley Hospital	Fayetteville	North Carolina
United States	Methodist Hospital	Houston	Texas
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Medcentral Hospital	Mansfield	Ohio
United States	Ochsner	New Orleans	Louisiana
United States	Christianna Care Health System	Newark	Delaware
United States	Waukesha Medical Center	West Allis	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Halyard Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Acquired Pneumonia	Pneumonia diagnosed during hospitalization	30 days postoperative
Secondary	Surgical Site Infection	surgical site infection diagnosed within 30 days post surgery	30 days postoperative
Secondary	Hospital Length of Stay	time (days) from date of admission to discharge	primary admission