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Multicenter Infection Surveillance Study Following Open Heart Surgery

Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00673712
Enrollment
647
Registered
2008-05-07
Start date
2008-04-30
Completion date
2012-09-30
Last updated
2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Surgery, Surgical Site Infection

Keywords

Coronary Artery Bypass Graft Surgery, Pneumonia, Surgical Site Infection

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.

Interventions

DEVICEContinuous Sternal Block

Elastomeric Pump for Continuous Infusion of Local Anesthetic

DRUGOpioid based analgesia

Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN

Sponsors

Halyard Health
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Hospital Acquired Pneumonia30 days postoperativePneumonia diagnosed during hospitalization

Secondary

MeasureTime frameDescription
Surgical Site Infection30 days postoperativesurgical site infection diagnosed within 30 days post surgery
Hospital Length of Stayprimary admissiontime (days) from date of admission to discharge

Countries

United States

Participant flow

Participants by arm

ArmCount
Continuous Sternal Block
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
321
Opioid Based Analgesia
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
326
Total647

Baseline characteristics

CharacteristicContinuous Sternal BlockTotalOpioid Based Analgesia
Age, Continuous64.3 years
STANDARD_DEVIATION 12.1
64.7 years
STANDARD_DEVIATION 11.8
65.2 years
STANDARD_DEVIATION 11.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants8 Participants4 Participants
Race (NIH/OMB)
Black or African American
29 Participants55 Participants26 Participants
Race (NIH/OMB)
More than one race
6 Participants18 Participants12 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
9 Participants16 Participants7 Participants
Race (NIH/OMB)
White
273 Participants550 Participants277 Participants
Region of Enrollment
United States
321 participants647 participants326 participants
Sex: Female, Male
Female
101 Participants198 Participants97 Participants
Sex: Female, Male
Male
220 Participants449 Participants229 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 3210 / 326
serious
Total, serious adverse events
0 / 3210 / 326

Outcome results

Primary

Hospital Acquired Pneumonia

Pneumonia diagnosed during hospitalization

Time frame: 30 days postoperative

Population: all randomized subjects

ArmMeasureValue (NUMBER)
Continuous Sternal BlockHospital Acquired Pneumonia8 participants
Opioid Based AnalgesiaHospital Acquired Pneumonia18 participants
Secondary

Hospital Length of Stay

time (days) from date of admission to discharge

Time frame: primary admission

Population: all randomized subjects

ArmMeasureValue (MEAN)Dispersion
Continuous Sternal BlockHospital Length of Stay8.8 daysStandard Deviation 29.9
Opioid Based AnalgesiaHospital Length of Stay9.5 daysStandard Deviation 29.6
Secondary

Surgical Site Infection

surgical site infection diagnosed within 30 days post surgery

Time frame: 30 days postoperative

Population: all randomized subjects

ArmMeasureValue (NUMBER)
Continuous Sternal BlockSurgical Site Infection17 participants
Opioid Based AnalgesiaSurgical Site Infection19 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026