Multicenter Infection Surveillance Study Following Open Heart Surgery

This study has suspended participant recruitment.
(PENDING INTERIM ANALYSIS)
Sponsor:
Information provided by (Responsible Party):
I-Flow
ClinicalTrials.gov Identifier:
NCT00673712
First received: May 6, 2008
Last updated: August 31, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by I-Flow:

Primary Outcome Measures:
  • hospital acquired pneumonia [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:
  • ON-Q
  • PainBuster
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673712

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
Sponsors and Collaborators
I-Flow
Investigators
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
Narcotics
Analgesics

ClinicalTrials.gov processed this record on September 11, 2014