Cardiac Dysfunction in Critically Ill Covid-19 Patients

NCT ID: NCT06197256

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-07
• Study Completion Date: 2021-02-11

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Törnberg, MD PhD

Role: STUDY_DIRECTOR

KI DS

Locations

Danderyds Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

iNO Cardiac

Identifier Type: -

Identifier Source: org_study_id