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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Acute Lung Injury
• COVID-19
• Covid19
• Pulmonary Edema
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Ventilation Perfusion Mismatch

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