Clinical trial NCT06197256: Cardiac Dysfunction in Critically Ill Covid-19 Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
ARDS, Human
Cardiac Failure
Right Ventricular Dysfunction
Left Ventricular Dysfunction
Pulmonary Hypertension
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2024-01-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Delta MPAP
timeFrame: 3-5 days
measure: Delta RV GLS
timeFrame: 3-5 days
measure: Delta TAPSE
timeFrame: 3-5 days
Secondary outcomes:
measure: Delta EF
timeFrame: 3-5 days
measure: Delta CI
timeFrame: 3-5 days
measure: Delta LV GLS
timeFrame: 3-5 days
measure: Rates of LV failure detected by LV GLS compared to EF
timeFrame: Presented both at baseline and followup
measure: Rates of RV failure detected by RV GLS compared to TAPSE
timeFrame: Presented both at baseline and followup
measure: Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurements
timeFrame: 3-5 days
Other outcomes:
measure: Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurements
timeFrame: Baseline and followup 3-5 days later
Locations:
city: Stockholm
country: Sweden
facility: Danderyds Hospital
Study officials:
affiliation: KI DS
name: Daniel Törnberg, MD PhD
role: STUDY_DIRECTOR
References: