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Cardiac Dysfunction in Critically Ill Covid-19 Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06197256
Enrollment
39
Registered
2024-01-09
Start date
2020-05-07
Completion date
2021-02-11
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human, Cardiac Failure, COVID-19, Left Ventricular Dysfunction, Pulmonary Hypertension, Right Ventricular Dysfunction

Brief 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.

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.

Interventions

None listed

Sponsors

Karolinska Institutet
CollaboratorOTHER
Region Stockholm
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 (

Design outcomes

Primary

MeasureTime frameDescription
Delta TAPSE3-5 daysDifference in TAPSE, measured at baseline and at followup
Delta MPAP3-5 daysDifference in MPAP, measured at baseline and at followup
Delta RV GLS3-5 daysDifference in RV GLS, measured at baseline and at followup

Secondary

MeasureTime frameDescription
Delta LV GLS3-5 daysDifference in LV GLS, measured at baseline and at followup
Rates of LV failure detected by LV GLS compared to EFPresented both at baseline and followupComparison of the amount of patients with LV failure for LV GLS and for EF, presented at both timepoints
Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurements3-5 daysRegression analysis will be performed to check for association between these potential confounders
Rates of RV failure detected by RV GLS compared to TAPSEPresented both at baseline and followupComparison of the amount of patients with RV failure for RV GLS and for TAPSE, presented at both timepoints
Delta EF3-5 daysDifference in EF, measured at baseline and at followup
Delta CI3-5 daysDifference in CI, measured at baseline and at followup

Other

MeasureTime frameDescription
Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurementsBaseline and followup 3-5 days laterRegression analysis will be performed to check for association between these potential confounders and RV function, to be corrected for if applicable

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026