- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07619274
Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
Right heart dysfunction remains a frequent cause of morbidity and mortality after cardiac surgery. Respiratory acidosis, particularly when accompanied by hypoxemia, plays a significant role in right heart failure, primarily by increasing right ventricular afterload through pulmonary vasoconstriction and elevated pulmonary arterial pressures. This phenomenon leads to increased right ventricular workload, causing dilation, decreased contractility, and ultimately right heart failure. The study aims to evaluate the effect of respiratory acidosis on right ventricular function after cardiac surgery.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Post hoc analysis of data from two separate studies previously approved by the Research Ethics Board NCT05886413 and NCT06826794. A stratification according to respiratory acidosis defined by a pH <7.35 with PaCO₂ >45mmHg on the first arterial blood gas analysis at the intensive care unit arrival will be done.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Etienne Couture
- Telefonnummer: 1-418-656-8711
- E-post: etienne.couture.3@ulaval.ca
Studiesteder
-
-
Quebec
-
Québec, Quebec, Canada, G1V4G5
- Rekruttering
- Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
-
Ta kontakt med:
- Etienne Couture
- Telefonnummer: 418-656-8711
- E-post: etienne.couture.3@ulaval.ca
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Adult patients who underwent cardiac surgery mechanically ventilated in controlled mode, and had an arterial blood gas within the first hour following admission.
Beskrivelse
Inclusion Criteria:
- Previously included and complete study NCT05886413 or NCT06826794
Exclusion Criteria:
- Absence of one or more of the following hemodynamic measurements: systolic or diastolic pulmonary artery pressure, central venous pressure, cardiac output
- Absence of arterial blood gas on arrival to the intensive care unit
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: RETROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Retrospective cohort
Completed study. Adult patients who underwent cardiac surgery were included if they were admitted to the intensive care unit immediately after surgery, mechanically ventilated in controlled mode, and had an arterial blood gas within the first hour following admission. |
No intervention |
|
Prospective cohort
Completed study. Adult patient included on open-label randomized study, comparing clinician-chosen initial mechanical ventilation parameters to those recommended by an algorithm immediately after ICU admission. |
No intervention |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Right ventricular function per central hemodynamic assessment
Tidsramme: At intensive care unit admission - within the first 4 hours
|
Calculation of different predictor: Cardiac index, PAPi (pulmonary artery pulse pressure over central venous pressure) , RVSWI ((mean pulmonary artery pressure- central venous pressure) X stroke volume index X 0.0136) and RV-CPO |
At intensive care unit admission - within the first 4 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intensive care unit length of stay
Tidsramme: Up to 28 days
|
Intensive care unit admission through Intensive care unit discharge |
Up to 28 days
|
|
Mechanical ventilation duration
Tidsramme: Day 28
|
Time spent with invasive mechanical ventilation between intensive care unit admission and hospital discharge |
Day 28
|
|
Vasopressor duration
Tidsramme: Day 28
|
Duration of vasopressor or inotrope administration |
Day 28
|
|
Acute renal failure
Tidsramme: Day 28
|
Rate of acute renal failure during coronary unit length of stay. Renal failure will be defined according to the usual criteria, i.e., an increase of >27 umol/L creatinine in 48 hours or 1.5x over the baseline |
Day 28
|
|
Mortality
Tidsramme: Day 28
|
Mortality in intensive care unit |
Day 28
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2027-4604
Plan for individuelle deltakerdata (IPD)
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