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

15. februar 2017 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

6844

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tilbagevirkende kraft

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vanderbilt University

Samarbejdspartnere

Edwards Lifesciences

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2016

Primær færdiggørelse (Faktiske)

1. november 2016

Studieafslutning (Faktiske)

1. november 2016

Datoer for studieregistrering

Først indsendt

18. oktober 2016

Først indsendt, der opfyldte QC-kriterier

10. november 2016

Først opslået (Skøn)

15. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 161377

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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