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Completed

NCT Number: NCT06197256

Cardiac Dysfunction in Critically Ill Covid-19 Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (exclusion criteria for this sub-study).

Treatment and study plan

Primary outcomes

  1. Delta MPAP

    Time frame: 3-5 days

    Difference in MPAP, measured at baseline and at followup

  2. Delta RV GLS

    Time frame: 3-5 days

    Difference in RV GLS, measured at baseline and at followup

  3. Delta TAPSE

    Time frame: 3-5 days

    Difference in TAPSE, measured at baseline and at followup

Secondary outcomes

  1. Delta EF

    Time frame: 3-5 days

    Difference in EF, measured at baseline and at followup

  2. Delta CI

    Time frame: 3-5 days

    Difference in CI, measured at baseline and at followup

  3. Delta LV GLS

    Time frame: 3-5 days

    Difference in LV GLS, measured at baseline and at followup

  4. Rates of LV failure detected by LV GLS compared to EF

    Time frame: Presented both at baseline and followup

    Comparison of the amount of patients with LV failure for LV GLS and for EF, presented at both timepoints

  5. Rates of RV failure detected by RV GLS compared to TAPSE

    Time frame: Presented both at baseline and followup

    Comparison of the amount of patients with RV failure for RV GLS and for TAPSE, presented at both timepoints

  6. Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurements

    Time frame: 3-5 days

    Regression analysis will be performed to check for association between these potential confounders

Other outcomes

  1. Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurements

    Time frame: Baseline and followup 3-5 days later

    Regression analysis will be performed to check for association between these potential confounders and RV function, to be corrected for if applicable

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 9, 2024
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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