- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07619274
Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
May 28, 2026 updated by: François Lellouche, Laval University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Etienne Couture
- Phone Number: 1-418-656-8711
- Email: etienne.couture.3@ulaval.ca
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1V4G5
- Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients who underwent cardiac surgery mechanically ventilated in controlled mode, and had an arterial blood gas within the first hour following admission.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Right ventricular function per central hemodynamic assessment
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intensive care unit length of stay
Time Frame: Up to 28 days
|
Intensive care unit admission through Intensive care unit discharge
|
Up to 28 days
|
|
Mechanical ventilation duration
Time Frame: Day 28
|
Time spent with invasive mechanical ventilation between intensive care unit admission and hospital discharge
|
Day 28
|
|
Vasopressor duration
Time Frame: Day 28
|
Duration of vasopressor or inotrope administration
|
Day 28
|
|
Acute renal failure
Time Frame: 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
Time Frame: Day 28
|
Mortality in intensive care unit
|
Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
May 8, 2026
First Submitted That Met QC Criteria
May 28, 2026
First Posted (Actual)
June 1, 2026
Study Record Updates
Last Update Posted (Actual)
June 1, 2026
Last Update Submitted That Met QC Criteria
May 28, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2027-4604
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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