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NCT Number: NCT02964026

Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Artery Catheter

Device

PAC must be placed between the day of admission and the day following a qualifying cardiac surgery

Other names: Swan-Ganz catheter

Primary outcomes

  1. Hospital mortality during index visit

    Time frame: Admission through up to 180 days (hospital discharge)

  2. Hospital length-of-stay (LOS)

    Time frame: Admission through up to 180 days (hospital discharge)

    Index hospital visit LOS

  3. Hospital readmission

    Time frame: Through 30 days

    Rate of hospital readmissions

  4. Hospital readmission

    Time frame: Through 60 days

    Rate of hospital readmissions

  5. Hospital readmission

    Time frame: Through 90 days

    Rate of hospital readmissions

  6. Major Adverse Cardiac Events (MACE)

    Time frame: Through 30 days

  7. Major Adverse Cardiac Events (MACE)

    Time frame: Through 60 days

  8. Major Adverse Cardiac Events (MACE)

    Time frame: Through 90 days

  9. Major morbidity composite

    Time frame: Through 30 days

  10. Major morbidity composite

    Time frame: Through 60 days

  11. Major morbidity composite

    Time frame: Through 90 days

Secondary outcomes

  1. New organ failure (cardiovascular, respiratory, coagulation, liver systems, renal)

    Time frame: Day 1 to discharge (up to 180 days)

  2. Requirement for mechanical ventilation

    Time frame: Day 1 to discharge (up to 180 days)

  3. Hemorrhage requiring blood transfusion

    Time frame: Day 1 to discharge (up to 180 days)

  4. Acute kidney injury (KDIGO staging)

    Time frame: Day 1 to day 10

  5. Infectious complications

    Time frame: Day 1 to discharge (up to 180 days)

  6. Gastrointestinal complication (hepatic)

    Time frame: Day 1 to discharge (up to 180 days)

  7. Respiratory failure

    Time frame: Day 1 to discharge (up to 180 days)

  8. Sequential Organ Failure Assessment (SOFA) scores

    Time frame: Day 1 to discharge (up to 180 days)

  9. Neurologic complication

    Time frame: Day 1 to discharge (up to 180 days)

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

Retrospective Analysis of Clinical Outcomes Associated With Use of the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients Within the Cerner HealthFacts Database

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 15, 2016
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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