Phase 4
N=647
Multicenter Infection Surveillance Study Following Open Heart Surgery
Surgery · Pneumonia · Surgical Site Infection
Bottom Line
View on ClinicalTrials.gov: NCT00673712 ↗Enrolled (actual)
647
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Hospital Acquired Pneumonia — 8; 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Continuous Sternal Block (Device); Opioid based analgesia (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Halyard Health
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Acquired Pneumonia |
8; 18 | — |
| SECONDARY Surgical Site Infection |
17; 19 | — |
| SECONDARY Hospital Length of Stay |
8.8; 9.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00673712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.