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

15. februar 2017 oppdatert av: Andrew Shaw, Vanderbilt University

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

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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

6844

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Retrospektiv

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Pulmonary artery catheter (PAC)
Patients received a PAC for monitoring purposes
Enhet: pulmonary artery catheter
PAC must be placed between the day of admission and the day following a qualifying cardiac surgery
Andre navn:
  • Swan-Ganz kateter
No pulmonary artery catheter (PAC)
Patients did not receive a PAC for monitoring purposes

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hospital mortality during index visit
Tidsramme: Admission through up to 180 days (hospital discharge)
Admission through up to 180 days (hospital discharge)
Hospital length-of-stay (LOS)
Tidsramme: Admission through up to 180 days (hospital discharge)
Index hospital visit LOS
Admission through up to 180 days (hospital discharge)
Hospital readmission
Tidsramme: Through 30 days
Rate of hospital readmissions
Through 30 days
Hospital readmission
Tidsramme: Through 60 days
Rate of hospital readmissions
Through 60 days
Hospital readmission
Tidsramme: Through 90 days
Rate of hospital readmissions
Through 90 days
Major Adverse Cardiac Events (MACE)
Tidsramme: Through 30 days
Through 30 days
Major Adverse Cardiac Events (MACE)
Tidsramme: Through 60 days
Through 60 days
Major Adverse Cardiac Events (MACE)
Tidsramme: Through 90 days
Through 90 days
Major morbidity composite
Tidsramme: Through 30 days
Through 30 days
Major morbidity composite
Tidsramme: Through 60 days
Through 60 days
Major morbidity composite
Tidsramme: Through 90 days
Through 90 days

Sekundære resultatmål

Resultatmål
Tidsramme
New organ failure (cardiovascular, respiratory, coagulation, liver systems, renal)
Tidsramme: Day 1 to discharge (up to 180 days)
Day 1 to discharge (up to 180 days)
Requirement for mechanical ventilation
Tidsramme: Day 1 to discharge (up to 180 days)
Day 1 to discharge (up to 180 days)
Hemorrhage requiring blood transfusion
Tidsramme: Day 1 to discharge (up to 180 days)
Day 1 to discharge (up to 180 days)
Acute kidney injury (KDIGO staging)
Tidsramme: Day 1 to day 10
Day 1 to day 10
Infectious complications
Tidsramme: Day 1 to discharge (up to 180 days)
Day 1 to discharge (up to 180 days)
Gastrointestinal complication (hepatic)
Tidsramme: Day 1 to discharge (up to 180 days)
Day 1 to discharge (up to 180 days)
Respiratory failure
Tidsramme: Day 1 to discharge (up to 180 days)
Day 1 to discharge (up to 180 days)
Sequential Organ Failure Assessment (SOFA) scores
Tidsramme: Day 1 to discharge (up to 180 days)
Day 1 to discharge (up to 180 days)
Neurologic complication
Tidsramme: Day 1 to discharge (up to 180 days)
Day 1 to discharge (up to 180 days)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vanderbilt University

Samarbeidspartnere

Edwards Lifesciences

Etterforskere

  • Hovedetterforsker: Andrew D Shaw, MB, FRCA, FFICM, FCCM, Vanderbilt University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2016

Primær fullføring (Faktiske)

1. november 2016

Studiet fullført (Faktiske)

1. november 2016

Datoer for studieregistrering

Først innsendt

18. oktober 2016

Først innsendt som oppfylte QC-kriteriene

10. november 2016

Først lagt ut (Anslag)

15. november 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 161377

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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