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OpenTrials
Completed

NCT Number: NCT00673712

Multicenter Infection Surveillance Study Following Open Heart Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Vincents East, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Sternal Block

Device

Elastomeric Pump for Continuous Infusion of Local Anesthetic

Other names: ON-Q, PainBuster

Opioid based analgesia

Drug

Opioid Analgesic agents delivered by:

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

Other names: PCA

Primary outcomes

  1. Hospital Acquired Pneumonia

    Time frame: 30 days postoperative

    Pneumonia diagnosed during hospitalization

Secondary outcomes

  1. Surgical Site Infection

    Time frame: 30 days postoperative

    surgical site infection diagnosed within 30 days post surgery

  2. Hospital Length of Stay

    Time frame: primary admission

    time (days) from date of admission to discharge

Sponsors and collaborators

Lead sponsor

Halyard Health

Industry

Registry information

Official study title

Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 7, 2008
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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