Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients
15 februari 2017 uppdaterad 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
6844
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Pulmonary artery catheter (PAC)
Patients received a PAC for monitoring purposes
|
PAC must be placed between the day of admission and the day following a qualifying cardiac surgery
Andra namn:
|
|
No pulmonary artery catheter (PAC)
Patients did not receive a PAC for monitoring purposes
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hospital mortality during index visit
Tidsram: Admission through up to 180 days (hospital discharge)
|
Admission through up to 180 days (hospital discharge)
|
|
|
Hospital length-of-stay (LOS)
Tidsram: Admission through up to 180 days (hospital discharge)
|
Index hospital visit LOS
|
Admission through up to 180 days (hospital discharge)
|
|
Hospital readmission
Tidsram: Through 30 days
|
Rate of hospital readmissions
|
Through 30 days
|
|
Hospital readmission
Tidsram: Through 60 days
|
Rate of hospital readmissions
|
Through 60 days
|
|
Hospital readmission
Tidsram: Through 90 days
|
Rate of hospital readmissions
|
Through 90 days
|
|
Major Adverse Cardiac Events (MACE)
Tidsram: Through 30 days
|
Through 30 days
|
|
|
Major Adverse Cardiac Events (MACE)
Tidsram: Through 60 days
|
Through 60 days
|
|
|
Major Adverse Cardiac Events (MACE)
Tidsram: Through 90 days
|
Through 90 days
|
|
|
Major morbidity composite
Tidsram: Through 30 days
|
Through 30 days
|
|
|
Major morbidity composite
Tidsram: Through 60 days
|
Through 60 days
|
|
|
Major morbidity composite
Tidsram: Through 90 days
|
Through 90 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
New organ failure (cardiovascular, respiratory, coagulation, liver systems, renal)
Tidsram: Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Requirement for mechanical ventilation
Tidsram: Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Hemorrhage requiring blood transfusion
Tidsram: Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Acute kidney injury (KDIGO staging)
Tidsram: Day 1 to day 10
|
Day 1 to day 10
|
|
Infectious complications
Tidsram: Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Gastrointestinal complication (hepatic)
Tidsram: Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Respiratory failure
Tidsram: Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Sequential Organ Failure Assessment (SOFA) scores
Tidsram: Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Neurologic complication
Tidsram: Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Andrew D Shaw, MB, FRCA, FFICM, FCCM, Vanderbilt University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2016
Primärt slutförande (Faktisk)
1 november 2016
Avslutad studie (Faktisk)
1 november 2016
Studieregistreringsdatum
Först inskickad
18 oktober 2016
Först inskickad som uppfyllde QC-kriterierna
10 november 2016
Första postat (Uppskatta)
15 november 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 februari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 februari 2017
Senast verifierad
1 februari 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 161377
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
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