NCT02964026

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,844 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thoracic Surgery
• Cardiac Surgery
• Heart Surgery
• Heart Transplant

Interventions

Type	Name	Description
DEVICE	pulmonary artery catheter	PAC must be placed between the day of admission and the day following a qualifying cardiac surgery

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-11-15
• Last updated: 2017-02-17