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Multicenter Infection Surveillance Study Following Open Heart Surgery

Primary Purpose

Surgery, Pneumonia, Surgical Site Infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Continuous Sternal Block
Opioid based analgesia
Sponsored by
Halyard Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring Coronary Artery Bypass Graft Surgery, Pneumonia, Surgical Site Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Vincents East
  • Christianna Care Health System
  • University of Kentucky Medical Center
  • Ochsner
  • Cape Fear valley Hospital
  • Medcentral Hospital
  • Methodist Hospital
  • Waukesha Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous Sternal Block

Opioid based analgesia

Arm Description

Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system

Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics

Outcomes

Primary Outcome Measures

Hospital Acquired Pneumonia
Pneumonia diagnosed during hospitalization

Secondary Outcome Measures

Surgical Site Infection
surgical site infection diagnosed within 30 days post surgery
Hospital Length of Stay
time (days) from date of admission to discharge

Full Information

First Posted
May 6, 2008
Last Updated
December 18, 2017
Sponsor
Halyard Health
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1. Study Identification

Unique Protocol Identification Number
NCT00673712
Brief Title
Multicenter Infection Surveillance Study Following Open Heart Surgery
Official Title
Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Halyard Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Pneumonia, Surgical Site Infection
Keywords
Coronary Artery Bypass Graft Surgery, Pneumonia, Surgical Site Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
647 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Sternal Block
Arm Type
Experimental
Arm Description
Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
Arm Title
Opioid based analgesia
Arm Type
Active Comparator
Arm Description
Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics
Intervention Type
Device
Intervention Name(s)
Continuous Sternal Block
Other Intervention Name(s)
ON-Q, PainBuster
Intervention Description
Elastomeric Pump for Continuous Infusion of Local Anesthetic
Intervention Type
Drug
Intervention Name(s)
Opioid based analgesia
Other Intervention Name(s)
PCA
Intervention Description
Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Primary Outcome Measure Information:
Title
Hospital Acquired Pneumonia
Description
Pneumonia diagnosed during hospitalization
Time Frame
30 days postoperative
Secondary Outcome Measure Information:
Title
Surgical Site Infection
Description
surgical site infection diagnosed within 30 days post surgery
Time Frame
30 days postoperative
Title
Hospital Length of Stay
Description
time (days) from date of admission to discharge
Time Frame
primary admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Husain, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincents East
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Christianna Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Name
Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Cape Fear valley Hospital
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Medcentral Hospital
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44903
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Waukesha Medical Center
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States

12. IPD Sharing Statement

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Multicenter Infection Surveillance Study Following Open Heart Surgery

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