Thoracic SurgeryNCT02964026
Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients
An observational study of Thoracic Surgery and Cardiac Surgery, run by Vanderbilt University.
Trial summary
The primary objective for this retrospective Electronic Health Record (EHR) analysis is to evaluate the clinical outcomes associated with the utilization of a pulmonary artery catheter (PAC), for monitoring purposes, within patients undergoing cardiac surgeries (isolated coronary artery bypass graft [CABG], valve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Cardiac Surgery, Heart Surgery
- What is being tested?
- pulmonary artery catheter
- Type of treatment
- Medical device
- How many people
- 6,844 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patients undergoing an isolated CABG, isolated valve, aortic procedure, complex nonvalvular procedures, multi-procedures or a heart transplant who receives or does not receive a pulmonary artery catheter (PAC) for monitoring purposes
Who may be able to join
- Patient undergoes a qualifying cardiac surgery between Jan 1, 2010 and January 1, 2015. If multiple qualifying surgeries are present, the first in database will be utilized
- Inpatient with a LOS of at least 48 hours
- Treated arm receives a PAC for monitoring purposes within admission date and qualifying cardiac surgical day plus one via specified ICD-9 or CPT-4 codes, or EHR recorded PAC readings
Who cannot join
- Cardiac surgery patients with age <18 years on index procedure date
- Non-treated arm derived from an institution which does not have database documented use of ICD-9 or CPT-4 PAC placement codes for monitoring purposes [Lessens the likelihood that the untreated arm is indeed treated by ensuring that the patient would likely be coded if he/she had a PAC in place for monitoring purposes]
- Patient record must have the demographics populated of age, gender, and race. ICD-9 diagnosis and procedure codes must be present in record for index visit, as well as medications administered over index visit
- Patient must be treated at a hospital which performs a minimum of 100 qualifying cardiac procedures per year
About this study
Official title: Retrospective Analysis of Clinical Outcomes Associated With Use of the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients Within the Cerner HealthFacts Database
The primary objective for this retrospective Electronic Health Record (EHR) analysis is to evaluate the clinical outcomes associated with the utilization of a pulmonary artery catheter (PAC), for monitoring purposes, within patients undergoing cardiac surgeries (isolated coronary artery bypass graft [CABG], valve, aortic surgery, multi-procedures, other complex nonvalvular procedures and heart transplants). The study will be conducted using prospectively collected hospital inpatient data over a duration of over 5 years (Jan. 1, 2010 - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas City, MO).
Read the detailed description
A retrospective study will be conducted using prospectively collected hospital inpatient data over a duration of over 5 years (Jan. 1, 2010 - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas City, MO). Patients who underwent a qualifying cardiac surgery (verified through use of selected valid International Classification of Diseases-9 procedure codes and/or Current Procedural Terminology [CPT] codes) will be included. Each patient's cohort designation will be defined based upon whether he/she did or did not receive a pulmonary artery catheter (PAC) for monitoring purposes. Propensity scores, which take into account patient and hospital demographics, patient comorbidities, surgical type (isolated coronary artery bypass graft [CABG], valve, aortic surgery, multi-procedures, other complex nonvalvular procedures and heart transplants), and pre-operative condition (via an adapted EuroSCORE II) will be utilized to "match" patients who received a PAC for monitoring purposes with those who did not, to form a matched study cohort. Clinical outcomes will be monitored through index visit discharge and up to 90 days post index visit discharge.
- Conditions
- Thoracic Surgery, Cardiac Surgery, Heart Surgery, Heart Transplant
- Being tested
- pulmonary artery catheter
- Keywords
- pulmonary artery catheter, Swan-Ganz catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary artery catheterDevice
Also called Swan-Ganz catheter
PAC must be placed between the day of admission and the day following a qualifying cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary artery catheter (PAC) | Patients received a PAC for monitoring purposes Receives: Device: pulmonary artery catheter | |
| No pulmonary artery catheter (PAC) | Patients did not receive a PAC for monitoring purposes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality during index visit
Measured: Admission through up to 180 days (hospital discharge)
Hospital length-of-stay (LOS)
Index hospital visit LOS
Measured: Admission through up to 180 days (hospital discharge)
Hospital readmission
Rate of hospital readmissions
Measured: Through 30 days
Hospital readmission
Rate of hospital readmissions
Measured: Through 60 days
Hospital readmission
Rate of hospital readmissions
Measured: Through 90 days
Major Adverse Cardiac Events (MACE)
Measured: Through 30 days
Major Adverse Cardiac Events (MACE)
Measured: Through 60 days
Major Adverse Cardiac Events (MACE)
Measured: Through 90 days
Major morbidity composite
Measured: Through 30 days
Major morbidity composite
Measured: Through 60 days
Major morbidity composite
Measured: Through 90 days
Secondary outcomes (9)
New organ failure (cardiovascular, respiratory, coagulation, liver systems, renal)
Measured: Day 1 to discharge (up to 180 days)
Requirement for mechanical ventilation
Measured: Day 1 to discharge (up to 180 days)
Hemorrhage requiring blood transfusion
Measured: Day 1 to discharge (up to 180 days)
Acute kidney injury (KDIGO staging)
Measured: Day 1 to day 10
Infectious complications
Measured: Day 1 to discharge (up to 180 days)
Gastrointestinal complication (hepatic)
Measured: Day 1 to discharge (up to 180 days)
Respiratory failure
Measured: Day 1 to discharge (up to 180 days)
Sequential Organ Failure Assessment (SOFA) scores
Measured: Day 1 to discharge (up to 180 days)
Neurologic complication
Measured: Day 1 to discharge (up to 180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,844 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Andrew Shaw, Vanderbilt University
- Investigators
- Andrew D Shaw, MB, FRCA, FFICM, FCCM, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964026
- Sponsor's protocol ID
- 161377
- Status last verified
- Feb 2017
- First submitted
- 18 Oct 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Shaw AD, Mythen MG, Shook D, Hayashida DK, Zhang X, Skaar JR, Iyengar SS, Munson SH. Pulmonary artery catheter use in adult patients undergoing cardiac surgery: a retrospective, cohort study. Perioper Med (Lond). 2018 Oct 25;7:24. doi: 10.1186/s13741-018-0103-x. eCollection 2018.
PubMed 30386591
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Clinical Outcomes Associated With Use of the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients Within the Cerner HealthFacts Database
- ClinicalTrials.gov ID
- NCT02964026
- Acronym / sponsor ID
- 161377
- Conditions
- Thoracic Surgery, Cardiac Surgery, Heart Surgery, Heart Transplant
- Keywords
- pulmonary artery catheter, Swan-Ganz catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,844 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- Sep 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective for this retrospective Electronic Health Record (EHR) analysis is to evaluate the clinical outcomes associated with the utilization of a pulmonary artery catheter (PAC), for monitoring purposes, within patients undergoing cardiac surgeries (isolated coronary artery bypass graft [CABG], valve, aortic surgery, multi-procedures, other complex nonvalvular procedures and heart transplants). The study will be conducted using prospectively collected hospital inpatient data over a duration of over 5 years (Jan. 1, 2010 - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas City, MO).
Detailed description
A retrospective study will be conducted using prospectively collected hospital inpatient data over a duration of over 5 years (Jan. 1, 2010 - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas City, MO). Patients who underwent a qualifying cardiac surgery (verified through use of selected valid International Classification of Diseases-9 procedure codes and/or Current Procedural Terminology [CPT] codes) will be included. Each patient's cohort designation will be defined based upon whether he/she did or did not receive a pulmonary artery catheter (PAC) for monitoring purposes. Propensity scores, which take into account patient and hospital demographics, patient comorbidities, surgical type (isolated coronary artery bypass graft [CABG], valve, aortic surgery, multi-procedures, other complex nonvalvular procedures and heart transplants), and pre-operative condition (via an adapted EuroSCORE II) will be utilized to "match" patients who received a PAC for monitoring purposes with those who did not, to form a matched study cohort. Clinical outcomes will be monitored through index visit discharge and up to 90 days post index visit discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary artery catheter (PAC) | – | Device: pulmonary artery catheterPatients received a PAC for monitoring purposes |
| No pulmonary artery catheter (PAC) | – | –Patients did not receive a PAC for monitoring purposes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing an isolated CABG, isolated valve, aortic procedure, complex nonvalvular procedures, multi-procedures or a heart transplant who receives or does not receive a pulmonary artery catheter (PAC) for monitoring purposes
Key inclusion criteria (3 listed)
- Patient undergoes a qualifying cardiac surgery between Jan 1, 2010 and January 1, 2015. If multiple qualifying surgeries are present, the first in database will be utilized
- Inpatient with a LOS of at least 48 hours
- Treated arm receives a PAC for monitoring purposes within admission date and qualifying cardiac surgical day plus one via specified ICD-9 or CPT-4 codes, or EHR recorded PAC readings
Key exclusion criteria (4 listed)
- Cardiac surgery patients with age <18 years on index procedure date
- Non-treated arm derived from an institution which does not have database documented use of ICD-9 or CPT-4 PAC placement codes for monitoring purposes [Lessens the likelihood that the untreated arm is indeed treated by ensuring that the patient would likely be coded if he/she had a PAC in place for monitoring purposes]
- Patient record must have the demographics populated of age, gender, and race. ICD-9 diagnosis and procedure codes must be present in record for index visit, as well as medications administered over index visit
- Patient must be treated at a hospital which performs a minimum of 100 qualifying cardiac procedures per year
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 |
|---|---|---|
| pulmonary artery catheterAlso: Swan-Ganz catheterPAC must be placed between the day of admission and the day following a qualifying cardiac surgery | Device | Pulmonary artery catheter (PAC) |
Primary outcome
Hospital mortality during index visit
Time frame: Admission through up to 180 days (hospital discharge)
Hospital length-of-stay (LOS)
Time frame: Admission through up to 180 days (hospital discharge)
Index hospital visit LOS
Hospital readmission
Time frame: Through 30 days
Rate of hospital readmissions
Hospital readmission
Time frame: Through 60 days
Rate of hospital readmissions
Hospital readmission
Time frame: Through 90 days
Rate of hospital readmissions
Major Adverse Cardiac Events (MACE)
Time frame: Through 30 days
Major Adverse Cardiac Events (MACE)
Time frame: Through 60 days
Major Adverse Cardiac Events (MACE)
Time frame: Through 90 days
Major morbidity composite
Time frame: Through 30 days
Major morbidity composite
Time frame: Through 60 days
Major morbidity composite
Time frame: Through 90 days
9 secondary outcomes
New organ failure (cardiovascular, respiratory, coagulation, liver systems, renal)
Time frame: Day 1 to discharge (up to 180 days)
Requirement for mechanical ventilation
Time frame: Day 1 to discharge (up to 180 days)
Hemorrhage requiring blood transfusion
Time frame: Day 1 to discharge (up to 180 days)
Acute kidney injury (KDIGO staging)
Time frame: Day 1 to day 10
Infectious complications
Time frame: Day 1 to discharge (up to 180 days)
Gastrointestinal complication (hepatic)
Time frame: Day 1 to discharge (up to 180 days)
Respiratory failure
Time frame: Day 1 to discharge (up to 180 days)
Sequential Organ Failure Assessment (SOFA) scores
Time frame: Day 1 to discharge (up to 180 days)
Neurologic complication
Time frame: Day 1 to discharge (up to 180 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Derived from this study: PubMed 30386591Shaw AD, Mythen MG, Shook D, Hayashida DK, Zhang X, Skaar JR, Iyengar SS, Munson SH. Pulmonary artery catheter use in adult patients undergoing cardiac surgery: a retrospective, cohort study. Perioper Med (Lond). 2018 Oct 25;7:24. doi: 10.1186/s13741-018-0103-x. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Andrew D Shaw, MB, FRCA, FFICM, FCCM principal investigator
Vanderbilt University
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery and Cardiac Surgery, run by Vanderbilt University.
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 4 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 mortality during index visit (time frame: Admission through up to 180 days (hospital discharge)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02964026, which also lists 1 linked publication.
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 17 Feb 2017.