COVID-19NCT06197256
Cardiac Dysfunction in Critically Ill Covid-19 Patients
An observational study of COVID-19 and ARDS, Human, run by Region Stockholm at 1 site in Sweden.
Trial summary
We conducted an observation sub-study of the prospective randomized controlled trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure", in which we analysed the echocardiographic data collected both at baseline when patients where included and 3-5 days later for followup. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, ARDS, Human, Cardiac Failure
- How many people
- 39 participants
- Where
- 1 siteSweden
- Study dates
- 7 May 2020to 11 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: A population studied in the trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure", consisting of 40 patients recruited in the ICU at Danderyds Hospital at the height of the COVID-19 pandemic. The study population consisted of critically ill patients requiring mechanical ventilation suffering from verified COVID-19 with ARDS.
Who may be able to join
- Age ≥18.
- Positive PCR for COVID-19.
- Admission to the ICU.
- Endotracheal intubation and mechanical ventilation.
- Severe hypoxemia, defined by PaO2/FiO2 < 300 mmHg.
- Inclusion in the trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure"
Who cannot join
- Endotracheal intubation for >72h before inclusion.
- Do not resuscitate order or other limitation of care.
- Known pregnancy.
- Cases where the treating physician opposes inclusion due to safety concerns or considerations that renders inclusion unfeasible.
- Not having had echocardiography performed during the trial period (exclusion criteria for this sub-study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Right and Left Ventricular Dysfunction in Critically Ill COVID-19 Patients and the Effects of Inhaled Nitric Oxide: A Sub-study of a Prospective Randomized Controlled Trial
We conducted an observation sub-study of the prospective randomized controlled trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure", in which we analysed the echocardiographic data collected both at baseline when patients where included and 3-5 days later for followup.
Read the detailed description
We conducted an observation sub-study of the prospective randomized controlled trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure" which was conducted in 2020/2021 during the COVID-19 pandemic on patients with ARDS due to COVID and requiring mechanical ventialtion. Patients underwent echocardiography at baseline, and were then randomized either to control, or treatment with inhaled nitric oxide, starting at 80ppm and then 40ppm. Followup echocardiography was performed 3-5 days later, and all echocardiographies were conducted by highly experienced sonographeres certified by the European Association of Cardiovascular Imaging. Analysis of these cardiac ultrasounds focused on the amount of patients showing signs of pulmonary hypertension, right ventricular failure and left ventricular failure. Several parameters were used to estimate these, and we also aimed to evalute the utility of more novel measures such as RV and LV GLS for this use in the ICU.
- Conditions
- COVID-19, ARDS, Human, Cardiac Failure, Right Ventricular Dysfunction, Left Ventricular Dysfunction, Pulmonary Hypertension
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Heart Failure, Ventricular Dysfunction, Right, Ventricular Dysfunction, Left, Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta MPAP
Difference in MPAP, measured at baseline and at followup
Measured: 3-5 days
Delta RV GLS
Difference in RV GLS, measured at baseline and at followup
Measured: 3-5 days
Delta TAPSE
Difference in TAPSE, measured at baseline and at followup
Measured: 3-5 days
Secondary outcomes (6)
Delta EF
Difference in EF, measured at baseline and at followup
Measured: 3-5 days
Delta CI
Difference in CI, measured at baseline and at followup
Measured: 3-5 days
Delta LV GLS
Difference in LV GLS, measured at baseline and at followup
Measured: 3-5 days
Rates of LV failure detected by LV GLS compared to EF
Comparison of the amount of patients with LV failure for LV GLS and for EF, presented at both timepoints
Measured: Presented both at baseline and followup
Rates of RV failure detected by RV GLS compared to TAPSE
Comparison of the amount of patients with RV failure for RV GLS and for TAPSE, presented at both timepoints
Measured: Presented both at baseline and followup
Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurements
Regression analysis will be performed to check for association between these potential confounders
Measured: 3-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start7 May 2020
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Daniel Törnberg, MD PhD, Study director, KI DS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197256
- Sponsor's protocol ID
- iNO Cardiac
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 9 Jan 2024
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right and Left Ventricular Dysfunction in Critically Ill COVID-19 Patients and the Effects of Inhaled Nitric Oxide: A Sub-study of a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06197256
- Acronym / sponsor ID
- iNO Cardiac
- Conditions
- COVID-19, ARDS, Human, Cardiac Failure, Right Ventricular Dysfunction, Left Ventricular Dysfunction, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 7 May 2020 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 9 Jan 2024 (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.
We conducted an observation sub-study of the prospective randomized controlled trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure", in which we analysed the echocardiographic data collected both at baseline when patients where included and 3-5 days later for followup.
Detailed description
We conducted an observation sub-study of the prospective randomized controlled trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure" which was conducted in 2020/2021 during the COVID-19 pandemic on patients with ARDS due to COVID and requiring mechanical ventialtion. Patients underwent echocardiography at baseline, and were then randomized either to control, or treatment with inhaled nitric oxide, starting at 80ppm and then 40ppm. Followup echocardiography was performed 3-5 days later, and all echocardiographies were conducted by highly experienced sonographeres certified by the European Association of Cardiovascular Imaging. Analysis of these cardiac ultrasounds focused on the amount of patients showing signs of pulmonary hypertension, right ventricular failure and left ventricular failure. Several parameters were used to estimate these, and we also aimed to evalute the utility of more novel measures such as RV and LV GLS for this use in the ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A population studied in the trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure", consisting of 40 patients recruited in the ICU at Danderyds Hospital at the height of the COVID-19 pandemic. The study population consisted of critically ill patients requiring mechanical ventilation suffering from verified COVID-19 with ARDS.
Key inclusion criteria (6 listed)
- Age ≥18.
- Positive PCR for COVID-19.
- Admission to the ICU.
- Endotracheal intubation and mechanical ventilation.
- Severe hypoxemia, defined by PaO2/FiO2 < 300 mmHg.
Key exclusion criteria (5 listed)
- Endotracheal intubation for >72h before inclusion.
- Do not resuscitate order or other limitation of care.
- Known pregnancy.
- Cases where the treating physician opposes inclusion due to safety concerns or considerations that renders inclusion unfeasible.
- Not having had echocardiography performed during the trial period (exclusion criteria for this sub-study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delta MPAP
Time frame: 3-5 days
Difference in MPAP, measured at baseline and at followup
Delta RV GLS
Time frame: 3-5 days
Difference in RV GLS, measured at baseline and at followup
Delta TAPSE
Time frame: 3-5 days
Difference in TAPSE, measured at baseline and at followup
6 secondary outcomes
Delta EF
Time frame: 3-5 days
Delta CI
Time frame: 3-5 days
Delta LV GLS
Time frame: 3-5 days
Rates of LV failure detected by LV GLS compared to EF
Time frame: Presented both at baseline and followup
Rates of RV failure detected by RV GLS compared to TAPSE
Time frame: Presented both at baseline and followup
Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurements
Time frame: 3-5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Daniel Törnberg, MD PhD study director
KI DS
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 COVID-19 and ARDS, Human, run by Region Stockholm at 1 site in Sweden.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jan 2024. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta MPAP (time frame: 3-5 days). The study lists 3 primary outcomes in all. 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 9 Jan 2024.