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CompletedNCT06197256Updated Jan 9, 2024

Cardiac Dysfunction in Critically Ill Covid-19 Patients

An observational study in COVID-19, ARDS, Human and Cardiac Failure, sponsored by Region Stockholm. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by Region Stockholm · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
39
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • COVID-19
  • ARDS, Human
  • Cardiac Failure
  • Right Ventricular Dysfunction
  • Left Ventricular Dysfunction
  • Pulmonary Hypertension
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 39 is below the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Region Stockholm is the lead sponsor of 121 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
39 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Delta MPAP

    Difference in MPAP, measured at baseline and at followup

    Time frame: 3-5 days

  2. Delta RV GLS

    Difference in RV GLS, measured at baseline and at followup

    Time frame: 3-5 days

  3. Delta TAPSE

    Difference in TAPSE, measured at baseline and at followup

    Time frame: 3-5 days

Secondary outcomes

  1. Delta EF

    Difference in EF, measured at baseline and at followup

    Time frame: 3-5 days

  2. Delta CI

    Difference in CI, measured at baseline and at followup

    Time frame: 3-5 days

  3. Delta LV GLS

    Difference in LV GLS, measured at baseline and at followup

    Time frame: 3-5 days

  4. 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

    Time frame: Presented both at baseline and followup

  5. 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

    Time frame: Presented both at baseline and followup

  6. 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

    Time frame: 3-5 days

Other outcomes

  1. 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 and RV function, to be corrected for if applicable

    Time frame: Baseline and followup 3-5 days later

07

Study locations

1 site
  • Danderyds Hospital
    Stockholm, 182 57, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2020 to primary completion in Feb 2021, 9 months.

Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 9 months is below that.

Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2024
First posted
Jan 9, 2024
StartActual
May 7, 2020
Primary completionActual
Feb 11, 2021
CompletionActual
Feb 11, 2021
Last update
Jan 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06197256
Lead sponsor
Region Stockholm
Responsible party
Sponsor
First posted
Jan 9, 2024
Start date
May 7, 2020
Primary completion
Feb 11, 2021
Completion
Feb 11, 2021
Last update
Jan 9, 2024

Study contacts

Daniel Törnberg, MD PhD
study director · KI DS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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