Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients
Retrospective Analysis of Clinical Outcomes Associated With Use of the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients Within the Cerner HealthFacts Database
1 other identifier
observational
6,844
0 countries
N/A
Brief 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, 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 15, 2016
CompletedFebruary 17, 2017
February 1, 2017
2 months
October 18, 2016
February 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Hospital mortality during index visit
Admission through up to 180 days (hospital discharge)
Hospital length-of-stay (LOS)
Index hospital visit LOS
Admission through up to 180 days (hospital discharge)
Hospital readmission
Rate of hospital readmissions
Through 30 days
Hospital readmission
Rate of hospital readmissions
Through 60 days
Hospital readmission
Rate of hospital readmissions
Through 90 days
Major Adverse Cardiac Events (MACE)
Through 30 days
Major Adverse Cardiac Events (MACE)
Through 60 days
Major Adverse Cardiac Events (MACE)
Through 90 days
Major morbidity composite
Through 30 days
Major morbidity composite
Through 60 days
Major morbidity composite
Through 90 days
Secondary Outcomes (9)
New organ failure (cardiovascular, respiratory, coagulation, liver systems, renal)
Day 1 to discharge (up to 180 days)
Requirement for mechanical ventilation
Day 1 to discharge (up to 180 days)
Hemorrhage requiring blood transfusion
Day 1 to discharge (up to 180 days)
Acute kidney injury (KDIGO staging)
Day 1 to day 10
Infectious complications
Day 1 to discharge (up to 180 days)
- +4 more secondary outcomes
Study Arms (2)
Pulmonary artery catheter (PAC)
Patients received a PAC for monitoring purposes
No pulmonary artery catheter (PAC)
Patients did not receive a PAC for monitoring purposes
Interventions
PAC must be placed between the day of admission and the day following a qualifying cardiac surgery
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt Universitylead
- Edwards Lifesciencescollaborator
Related Publications (1)
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.
PMID: 30386591DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew D Shaw, MB, FRCA, FFICM, FCCM
Vanderbilt University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Executive Vice Chair Department of Anesthesiology Executive Medical Director, Perioperative Services
Study Record Dates
First Submitted
October 18, 2016
First Posted
November 15, 2016
Study Start
September 1, 2016
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
February 17, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share