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

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ClinicalTrials.gov Identifier: NCT04508933
Recruitment Status : Not yet recruiting
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Olcay Dilken, Istanbul University-Cerrahpasa

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
Respiratory Distress Syndrome, Adult Ventilation Perfusion Mismatch Pulmonary Edema Covid19 Device: Extravascular Lung Water Index Device: Pulmonary Vascular Permeability Index

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Study Type : Observational
Estimated Enrollment : 10 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
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020


Group/Cohort 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




Primary Outcome Measures :
  1. Extravascular Lung Water Index [ Time Frame: 1 day ]
    The amount of fluid accumulated in the lung measured by transpulmonary thermodilution (ml/kg)

  2. Pulmonary vascular permeability index [ Time Frame: 1 day ]
    Integrity of the alveolocapillary barrier measured by transpulmonary thermodilution



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with ARDS in the adult ICU that have a TPTD catheter inserted since 2018 will be eligible for recruitment
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508933


Contacts
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Contact: Olcay Dilken, MD +90 554 737 87 09 olcaydilken@gmail.com

Locations
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Turkey
Istanbul University-Cerrahpaşa
Istanbul, Turkey
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Study Director: Yalım Dikmen, Prof Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
Publications of Results:
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Responsible Party: Olcay Dilken, Principal Investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04508933    
Other Study ID Numbers: 0308202247
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data available on reasonable request

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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, Istanbul University-Cerrahpasa:
ards
covid19
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Pulmonary Edema
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury