Cardiac Dysfunction in Critically Ill Covid-19 Patients

NCT06197256 | Completed

• 1 other identifier: iNO Cardiac
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Delta EF

  3-5 days

• Delta CI

  3-5 days

• Delta LV GLS

  3-5 days

• Rates of LV failure detected by LV GLS compared to EF

  Presented both at baseline and followup

• Rates of RV failure detected by RV GLS compared to TAPSE

  Presented both at baseline and followup

Other Outcomes (1)

• Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurements

  Baseline and followup 3-5 days later

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18.
• Positive PCR for COVID-19.
• Admission to the ICU.
• Endotracheal intubation and mechanical ventilation.
• Severe hypoxemia, defined by PaO2/FiO2 \< 300 mmHg.

You may not qualify if:

• Do not resuscitate order or other limitation of care.
• Known pregnancy.

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Danderyds Hospital

Stockholm, 182 57, Sweden

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome; Heart Failure; Ventricular Dysfunction, Right; Ventricular Dysfunction, Left; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Hypertension; Vascular Diseases

Study Officials

• Daniel Törnberg, MD PhD

  KI DS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 9, 2024
• Study Start: May 7, 2020
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)