Cardiac Dysfunction in Critically Ill Covid-19 Patients

Completed

• Conditions: Left Ventricular Dysfunction; Pulmonary Hypertension; COVID-19; ARDS, Human; Cardiac Failure; Right Ventricular Dysfunction

• Registration Number: NCT06197256
• Lead Sponsor: Region Stockholm

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.

Study Timeline

• Study Start: 2020-05-07
• Primary Completion: 2021-02-11
• Study Completion: 2021-02-11
• Status Verified: 2024-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delta MPAP	3-5 days	Difference in MPAP, measured at baseline and at followup
Delta RV GLS	3-5 days	Difference in RV GLS, measured at baseline and at followup
Delta TAPSE	3-5 days	Difference in TAPSE, measured at baseline and at followup

Secondary Outcome Measures

Name	Time	Method
Rates of RV failure detected by RV GLS compared to TAPSE	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
Delta CI	3-5 days	Difference in CI, measured at baseline and at followup
Rates of LV failure detected by LV GLS compared to EF	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
Delta LV GLS	3-5 days	Difference in LV GLS, measured at baseline and at followup
Delta EF	3-5 days	Difference in EF, measured at baseline and at followup
Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurements	3-5 days	Regression analysis will be performed to check for association between these potential confounders

Trial Locations

Locations (1)

Danderyds Hospital; 🇸🇪 Stockholm, Sweden