Multicenter Infection Surveillance Study Following Open Heart Surgery

• Sponsor: Halyard Health (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00673712
• Collaborator: (none)
• Enrollment: 647
• Locations: 8
• Arms: 2
• Duration (Months): 53
• Patients Per Site: 80.9
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery; Pneumonia; Surgical Site Infection	Device: Continuous Sternal Block; Drug: Opioid based analgesia	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 647 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: PCA

Outcome Measures

Primary Outcome Measures

1. Hospital Acquired Pneumonia [30 days postoperative]

   Pneumonia diagnosed during hospitalization

Secondary Outcome Measures

1. Surgical Site Infection [30 days postoperative]

   surgical site infection diagnosed within 30 days post surgery

2. Hospital Length of Stay [primary admission]

   time (days) from date of admission to discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	St. Vincents East	Birmingham	Alabama	United States	35235
2	Christianna Care Health System	Newark	Delaware	United States	19713
3	University of Kentucky Medical Center	Lexington	Kentucky	United States	40506
4	Ochsner	New Orleans	Louisiana	United States	70121
5	Cape Fear valley Hospital	Fayetteville	North Carolina	United States	28304
6	Medcentral Hospital	Mansfield	Ohio	United States	44903
7	Methodist Hospital	Houston	Texas	United States	77030
8	Waukesha Medical Center	West Allis	Wisconsin	United States	53227

Sponsors and Collaborators

• Halyard Health

Investigators

• Principal Investigator: Ali Husain, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Halyard Health
• ClinicalTrials.gov Identifier: NCT00673712
• Other Study ID Numbers: iflocv2008
• First Posted: May 7, 2008
• Last Update Posted: Jan 19, 2018
• Last Verified: Apr 1, 2015

• Keywords provided by Halyard Health: Coronary Artery Bypass Graft Surgery; Pneumonia; Surgical Site Infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Pneumonia; Surgical Wound Infection; Analgesics, Opioid

Study Results

Participant Flow

Arm/Group Title	Continuous Sternal Block	Opioid Based Analgesia
Arm/Group Description	Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic	Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Period Title: Overall Study
STARTED	321	326
COMPLETED	321	326
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Continuous Sternal Block	Opioid Based Analgesia	Total
Arm/Group Description	Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic	Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN	Total of all reporting groups
Overall Participants	321	326	647
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.3 (12.1)	65.2 (11.5)	64.7 (11.8)
Sex: Female, Male (Count of Participants)
Female	101 31.5%	97 29.8%	198 30.6%
Male	220 68.5%	229 70.2%	449 69.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 1.2%	4 1.2%	8 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	29 9%	26 8%	55 8.5%
White	273 85%	277 85%	550 85%
More than one race	6 1.9%	12 3.7%	18 2.8%
Unknown or Not Reported	9 2.8%	7 2.1%	16 2.5%
Region of Enrollment (participants) [Number]
United States	321 100%	326 100%	647 100%

Outcome Measures

1. Primary Outcome

Title	Hospital Acquired Pneumonia
Description	Pneumonia diagnosed during hospitalization
Time Frame	30 days postoperative

Outcome Measure Data

Analysis Population Description

all randomized subjects

Arm/Group Title	Continuous Sternal Block	Opioid Based Analgesia
Arm/Group Description	Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic	Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Measure Participants	321	326
Number [participants]	8 2.5%	18 5.5%

2. Secondary Outcome

Title	Surgical Site Infection
Description	surgical site infection diagnosed within 30 days post surgery
Time Frame	30 days postoperative

Outcome Measure Data

Analysis Population Description

all randomized subjects

Arm/Group Title	Continuous Sternal Block	Opioid Based Analgesia
Arm/Group Description	Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic	Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Measure Participants	321	326
Number [participants]	17 5.3%	19 5.8%

3. Secondary Outcome

Title	Hospital Length of Stay
Description	time (days) from date of admission to discharge
Time Frame	primary admission

Outcome Measure Data

Analysis Population Description

all randomized subjects

Arm/Group Title	Continuous Sternal Block	Opioid Based Analgesia
Arm/Group Description	Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic	Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Measure Participants	321	326
Mean (Standard Deviation) [days]	8.8 (29.9)	9.5 (29.6)

Adverse Events

Time Frame	30 days
Arm/Group Title	Continuous Sternal Block		Opioid Based Analgesia
Arm/Group Description	Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic		Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN
All Cause Mortality
	Continuous Sternal Block		Opioid Based Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Continuous Sternal Block		Opioid Based Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/321 (0%)		0/326 (0%)
Other (Not Including Serious) Adverse Events
	Continuous Sternal Block		Opioid Based Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/321 (0%)		0/326 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.