Respiratory Acidosis in ICU PatientsNCT07619274
Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
An observational study of Respiratory Acidosis in ICU Patients and Right Ventricular (RV) Dysfunction, run by Laval University at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Acidosis in ICU Patients, Right Ventricular (RV) Dysfunction, Hemodynamic Changes
- What is being tested?
- Not applicable- observational study
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- May 2026to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Previously included and complete study NCT05886413 or NCT06826794
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
Québec, Quebec, G1V4G5
About this study
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.
Read the 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.
- Conditions
- Respiratory Acidosis in ICU Patients, Right Ventricular (RV) Dysfunction, Hemodynamic Changes, Mechanical Ventilation
- Being tested
- Not applicable- observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Not applicable- observational study | |
| 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. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular function per central hemodynamic assessment
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
Measured: At intensive care unit admission - within the first 4 hours
Secondary outcomes (5)
Intensive care unit length of stay
Intensive care unit admission through Intensive care unit discharge
Measured: Up to 28 days
Mechanical ventilation duration
Time spent with invasive mechanical ventilation between intensive care unit admission and hospital discharge
Measured: Day 28
Vasopressor duration
Duration of vasopressor or inotrope administration
Measured: Day 28
Acute renal failure
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
Measured: Day 28
Mortality
Mortality in intensive care unit
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startMay 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Acidosis in ICU PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lellouche, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619274
- Sponsor's protocol ID
- 2027-4604
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07619274
- Acronym / sponsor ID
- 2027-4604
- Conditions
- Respiratory Acidosis in ICU Patients, Right Ventricular (RV) Dysfunction, Hemodynamic Changes, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Other: Not applicable- observational studyCompleted 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. |
| Prospective cohort | – | Other: Not applicable- observational studyCompleted 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Previously included and complete study NCT05886413 or NCT06826794
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNo intervention | Other | Prospective cohort, Retrospective cohort |
Primary outcome
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
5 secondary outcomes
Intensive care unit length of stay
Time frame: Up to 28 days
Mechanical ventilation duration
Time frame: Day 28
Vasopressor duration
Time frame: Day 28
Acute renal failure
Time frame: Day 28
Mortality
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Acidosis in ICU Patients and Right Ventricular (RV) Dysfunction, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Etienne Couture (1-418-656-8711, etienne.couture.3@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular function per central hemodynamic assessment (time frame: At intensive care unit admission - within the first 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.