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

Completed

• Conditions: Cardiac Surgery; Thoracic Surgery; Heart Surgery; Heart Transplant
• Interventions: Device: pulmonary artery catheter

• Registration Number: NCT02964026
• Lead Sponsor: Vanderbilt University

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-18
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6844

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary artery catheter (PAC)	pulmonary artery catheter	Patients received a PAC for monitoring purposes

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE)	Through 90 days
Hospital mortality during index visit	Admission through up to 180 days (hospital discharge)
Hospital length-of-stay (LOS)	Admission through up to 180 days (hospital discharge)	Index hospital visit LOS
Hospital readmission	Through 90 days	Rate of hospital readmissions
Major morbidity composite	Through 90 days

Secondary Outcome Measures

Name	Time	Method
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)
Acute kidney injury (KDIGO staging)	Day 1 to day 10
Gastrointestinal complication (hepatic)	Day 1 to discharge (up to 180 days)
Respiratory failure	Day 1 to discharge (up to 180 days)
Sequential Organ Failure Assessment (SOFA) scores	Day 1 to discharge (up to 180 days)
Neurologic complication	Day 1 to discharge (up to 180 days)
Hemorrhage requiring blood transfusion	Day 1 to discharge (up to 180 days)
Infectious complications	Day 1 to discharge (up to 180 days)