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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 182 57
    • Danderyds Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta MPAP	Difference in MPAP, measured at baseline and at followup	3-5 days
Delta RV GLS	Difference in RV GLS, measured at baseline and at followup	3-5 days
Delta TAPSE	Difference in TAPSE, measured at baseline and at followup	3-5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta EF	Difference in EF, measured at baseline and at followup	3-5 days
Delta CI	Difference in CI, measured at baseline and at followup	3-5 days
Delta LV GLS	Difference in LV GLS, measured at baseline and at followup	3-5 days
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	Presented both at baseline and followup
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	Presented both at baseline and followup
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	3-5 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and followup 3-5 days later

Collaborators and Investigators

• Sponsor: Region Stockholm
• Collaborators: Karolinska Institutet
• Investigators: Study Director: Daniel Törnberg, MD PhD, KI DS

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2020
• Primary Completion (Actual): February 11, 2021
• Study Completion (Actual): February 11, 2021

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Hypertension; Heart Failure; COVID-19; Hypertension, Pulmonary; Respiratory Distress Syndrome; Ventricular Dysfunction; Ventricular Dysfunction, Right; Ventricular Dysfunction, Left
• Other Study ID Numbers: iNO Cardiac

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No