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

October 21, 2021 updated by: Olcay Dilken, Istanbul University - Cerrahpasa (IUC)
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University-Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

August 8, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0308202247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data available on reasonable request

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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