SurgeryPhase 4NCT00673712
Multicenter Infection Surveillance Study Following Open Heart Surgery
A Phase 4 study testing Continuous Sternal Block and Opioid based analgesia in people with Surgery and Pneumonia, run by Halyard Health at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Pneumonia, Surgical Site Infection
- What is being tested?
- Continuous Sternal Block and Opioid based analgesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 647 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2008to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, >18 years of age;
- Scheduled for elective cardiac surgical procedure, including coronary revasculari-zation or valve surgery;
- Provision of informed consent
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
St. Vincents East
Birmingham, Alabama, 35235
Cape Fear valley Hospital
Fayetteville, North Carolina, 28304
Methodist Hospital
Houston, Texas, 77030
University of Kentucky Medical Center
Lexington, Kentucky, 40506
Medcentral Hospital
Mansfield, Ohio, 44903
Ochsner
New Orleans, Louisiana, 70121
Christianna Care Health System
Newark, Delaware, 19713
Waukesha Medical Center
West Allis, Wisconsin, 53227
About this study
Official title: Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures
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.
Read the 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.
- Conditions
- Surgery, Pneumonia, Surgical Site Infection
- Being tested
- Continuous Sternal Block, Opioid based analgesia
- Keywords
- Coronary Artery Bypass Graft Surgery, Pneumonia, Surgical Site Infection
- Medical subject headings
- Pneumonia, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Sternal BlockDevice
Also called ON-Q, PainBuster
Elastomeric Pump for Continuous Infusion of Local Anesthetic
Opioid based analgesiaDrug
Also called PCA
Opioid Analgesic agents delivered by:
PCA on demand mode IV injections PRN IM injections PRN Oral PRN
| Study group | Role | What they receive |
|---|---|---|
| Continuous Sternal Block | Experimental | Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Receives: Device: Continuous Sternal Block |
| Opioid based analgesia | Active comparator | Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Receives: Drug: Opioid based analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Acquired Pneumonia
Pneumonia diagnosed during hospitalization
Measured: 30 days postoperative
Secondary outcomes (2)
Surgical Site Infection
surgical site infection diagnosed within 30 days post surgery
Measured: 30 days postoperative
Hospital Length of Stay
time (days) from date of admission to discharge
Measured: primary admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halyard Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali Husain, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673712
- Sponsor's protocol ID
- iflocv2008
- Status last verified
- Apr 2015
- First submitted
- 6 May 2008
- Last updated
- 19 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures
- ClinicalTrials.gov ID
- NCT00673712
- Acronym / sponsor ID
- iflocv2008
- Conditions
- Surgery, Pneumonia, Surgical Site Infection
- Keywords
- Coronary Artery Bypass Graft Surgery, Pneumonia, Surgical Site Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- Halyard HealthIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 4 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Sternal Block | Experimental | Device: Continuous Sternal BlockContinuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system |
| Opioid based analgesia | Active comparator | Drug: Opioid based analgesiaOpioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women, >18 years of age;
- Scheduled for elective cardiac surgical procedure, including coronary revasculari-zation or valve surgery;
- Provision of informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Sternal BlockAlso: ON-Q, PainBusterElastomeric Pump for Continuous Infusion of Local Anesthetic | Device | Continuous Sternal Block |
| Opioid based analgesiaAlso: PCAOpioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN | Drug | Opioid based analgesia |
Primary outcome
Hospital Acquired Pneumonia
Time frame: 30 days postoperative
Pneumonia diagnosed during hospitalization
2 secondary outcomes
Surgical Site Infection
Time frame: 30 days postoperative
Hospital Length of Stay
Time frame: primary admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Husain, MD principal investigator
The Cleveland Clinic
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous Sternal Block and Opioid based analgesia in people with Surgery and Pneumonia, run by Halyard Health at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Acquired Pneumonia (time frame: 30 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.