Cardiac Dysfunction in Critically Ill Covid-19 Patients

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06197256
• Other study ID #: iNO Cardiac
• Status: Completed
• Start date: May 7, 2020
• Est. completion date: February 11, 2021

Study information

• Verified date: January 2024
• Source: Region Stockholm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 11, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• ARDS, Human
• Cardiac Failure
• COVID-19
• Heart Failure
• Hypertension, Pulmonary
• Left Ventricular Dysfunction
• Pulmonary Hypertension
• Respiratory Distress Syndrome
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left
• Ventricular Dysfunction, Right

Locations

Country	Name	City	State
Sweden	Danderyds Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Delta MPAP	Difference in MPAP, measured at baseline and at followup	3-5 days
Primary	Delta RV GLS	Difference in RV GLS, measured at baseline and at followup	3-5 days
Primary	Delta TAPSE	Difference in TAPSE, measured at baseline and at followup	3-5 days
Secondary	Delta EF	Difference in EF, measured at baseline and at followup	3-5 days
Secondary	Delta CI	Difference in CI, measured at baseline and at followup	3-5 days
Secondary	Delta LV GLS	Difference in LV GLS, measured at baseline and at followup	3-5 days
Secondary	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
Secondary	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
Secondary	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