- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Etienne Couture
- Telefonnummer: 1-418-656-8711
- E-post: etienne.couture.3@ulaval.ca
Studieorter
-
-
Quebec
-
Québec, Quebec, Kanada, G1V4G5
- Rekrytering
- Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
-
Kontakt:
- Etienne Couture
- Telefonnummer: 418-656-8711
- E-post: etienne.couture.3@ulaval.ca
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Adult patients who underwent cardiac surgery mechanically ventilated in controlled mode, and had an arterial blood gas within the first hour following admission.
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: RETROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Right ventricular function per central hemodynamic assessment
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intensive care unit length of stay
Tidsram: Up to 28 days
|
Intensive care unit admission through Intensive care unit discharge |
Up to 28 days
|
|
Mechanical ventilation duration
Tidsram: Day 28
|
Time spent with invasive mechanical ventilation between intensive care unit admission and hospital discharge |
Day 28
|
|
Vasopressor duration
Tidsram: Day 28
|
Duration of vasopressor or inotrope administration |
Day 28
|
|
Acute renal failure
Tidsram: 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
Tidsram: Day 28
|
Mortality in intensive care unit |
Day 28
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2027-4604
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