Clinical trial NCT02964026: Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Cardiac Surgery
Heart Surgery
Heart Transplant
Keywords: pulmonary artery catheter
Swan-Ganz catheter
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2016-11-15
Enrollment: 6844
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hospital mortality during index visit
timeFrame: Admission through up to 180 days (hospital discharge)
measure: Hospital length-of-stay (LOS)
timeFrame: Admission through up to 180 days (hospital discharge)
measure: Hospital readmission
timeFrame: Through 30 days
measure: Hospital readmission
timeFrame: Through 60 days
measure: Hospital readmission
timeFrame: Through 90 days
measure: Major Adverse Cardiac Events (MACE)
timeFrame: Through 30 days
measure: Major Adverse Cardiac Events (MACE)
timeFrame: Through 60 days
measure: Major Adverse Cardiac Events (MACE)
timeFrame: Through 90 days
measure: Major morbidity composite
timeFrame: Through 30 days
measure: Major morbidity composite
timeFrame: Through 60 days
measure: Major morbidity composite
timeFrame: Through 90 days
Secondary outcomes:
measure: New organ failure (cardiovascular, respiratory, coagulation, liver systems, renal)
timeFrame: Day 1 to discharge (up to 180 days)
measure: Requirement for mechanical ventilation
timeFrame: Day 1 to discharge (up to 180 days)
measure: Hemorrhage requiring blood transfusion
timeFrame: Day 1 to discharge (up to 180 days)
measure: Acute kidney injury (KDIGO staging)
timeFrame: Day 1 to day 10
measure: Infectious complications
timeFrame: Day 1 to discharge (up to 180 days)
measure: Gastrointestinal complication (hepatic)
timeFrame: Day 1 to discharge (up to 180 days)
measure: Respiratory failure
timeFrame: Day 1 to discharge (up to 180 days)
measure: Sequential Organ Failure Assessment (SOFA) scores
timeFrame: Day 1 to discharge (up to 180 days)
measure: Neurologic complication
timeFrame: Day 1 to discharge (up to 180 days)
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Andrew D Shaw, MB, FRCA, FFICM, FCCM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.