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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2024
Source Region Stockholm
Contact n/a
Is FDA regulated No
Health authority
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).

Study Design


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
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