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
NCT number | NCT06197256 |
Other study ID # | iNO Cardiac |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 7, 2020 |
Est. completion date | February 11, 2021 |
Verified date | January 2024 |
Source | Region Stockholm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Sweden | Danderyds Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Region Stockholm | Karolinska Institutet |
Sweden,
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 |
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