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

Cardiac Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964026
• Other study ID #: 161377
• Status: Completed
• Phase: N/A
• First received: October 18, 2016
• Last updated: February 15, 2017
• Start date: September 2016
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6844
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• pulmonary artery catheter
PAC must be placed between the day of admission and the day following a qualifying cardiac surgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Edwards Lifesciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital mortality during index visit		Admission through up to 180 days (hospital discharge)
Primary	Hospital length-of-stay (LOS)	Index hospital visit LOS	Admission through up to 180 days (hospital discharge)
Primary	Hospital readmission	Rate of hospital readmissions	Through 30 days
Primary	Hospital readmission	Rate of hospital readmissions	Through 60 days
Primary	Hospital readmission	Rate of hospital readmissions	Through 90 days
Primary	Major Adverse Cardiac Events (MACE)		Through 30 days
Primary	Major Adverse Cardiac Events (MACE)		Through 60 days
Primary	Major Adverse Cardiac Events (MACE)		Through 90 days
Primary	Major morbidity composite		Through 30 days
Primary	Major morbidity composite		Through 60 days
Primary	Major morbidity composite		Through 90 days
Secondary	New organ failure (cardiovascular, respiratory, coagulation, liver systems, renal)		Day 1 to discharge (up to 180 days)
Secondary	Requirement for mechanical ventilation		Day 1 to discharge (up to 180 days)
Secondary	Hemorrhage requiring blood transfusion		Day 1 to discharge (up to 180 days)
Secondary	Acute kidney injury (KDIGO staging)		Day 1 to day 10
Secondary	Infectious complications		Day 1 to discharge (up to 180 days)
Secondary	Gastrointestinal complication (hepatic)		Day 1 to discharge (up to 180 days)
Secondary	Respiratory failure		Day 1 to discharge (up to 180 days)
Secondary	Sequential Organ Failure Assessment (SOFA) scores		Day 1 to discharge (up to 180 days)
Secondary	Neurologic complication		Day 1 to discharge (up to 180 days)