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

• Sponsor: Istanbul University-Cerrahpasa (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04508933
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Adult; Ventilation Perfusion Mismatch; Pulmonary Edema; Covid19	Device: Extravascular Lung Water Index; Device: Pulmonary Vascular Permeability Index

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
• Anticipated Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Sep 30, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Typical ARDS ARDS due to non Covid19 causes	Device: Extravascular Lung Water Index; Measurement of the EVLWI; Device: Pulmonary Vascular Permeability Index; Measurement of the PVPI
C-ARDS ARDS due to Covid19	Device: Extravascular Lung Water Index; Measurement of the EVLWI; Device: Pulmonary Vascular Permeability Index; Measurement of the PVPI

Outcome Measures

Primary Outcome Measures

1. Extravascular Lung Water Index [1 day]

   The amount of fluid accumulated in the lung measured by transpulmonary thermodilution (ml/kg)

2. Pulmonary vascular permeability index [1 day]

   Integrity of the alveolocapillary barrier measured by transpulmonary thermodilution

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University-Cerrahpaşa	Istanbul		Turkey

Sponsors and Collaborators

• Istanbul University-Cerrahpasa

Investigators

• Study Director: Yalım Dikmen, Prof, Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Olcay Dilken, Principal Investigator, Istanbul University-Cerrahpasa
• ClinicalTrials.gov Identifier: NCT04508933
• Other Study ID Numbers: 0308202247
• First Posted: Aug 11, 2020
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Olcay Dilken, Principal Investigator, Istanbul University-Cerrahpasa: ards; covid19
• Additional relevant MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Pulmonary Edema; Acute Lung Injury

Study Results

No Results Posted as of Oct 26, 2021