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NCT04508933 Clinical Trial

Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients

Covid19 Clinical Trial

Official title:
Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04508933
Other study ID # 0308202247
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date December 31, 2020

Study information
Verified date October 2021
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Covid-19 also primarily affects endothelium that line up the alveoli. The resulting hypoxemia may differ from "typical" Acute Respiratory Distress Syndrome (ARDS) due to maldistribution of perfusion related to the ventilation. Thus, pathophysiology of Covid-19 ARDS is different, which requires different interventions than typical ARDS. The investigators will assess whether extravascular lung water index and permeability of the alveolar capillary differs from typical ARDS with transpulmonary thermodilution (TPTD) technique. Extravascular Lung Water Index (EVLWI) and Pulmonary Vascular Permeability Index (PVPI) will be compared.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 31, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ARDS defined by Berlin Criteria longer than 24 hours - Undergoing mechanical ventilation - Noradrenaline demand >0.1 mcg/kg/min Exclusion Criteria: - Not meeting ARDS criteria - Noninvasive mechanical ventilation - ARDS resolved shorter than 24 hours - Shock resolved

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Extravascular Lung Water Index
Measurement of the EVLWI
• Pulmonary Vascular Permeability Index
Measurement of the PVPI

Locations
Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Extravascular Lung Water Index The amount of fluid accumulated in the lung measured by transpulmonary thermodilution (ml/kg) 1 day
Primary Pulmonary vascular permeability index Integrity of the alveolocapillary barrier measured by transpulmonary thermodilution 1 day
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