Respiratory Distress Syndrome, AdultNCT04508933
Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
An observational study of Respiratory Distress Syndrome, Adult and Ventilation Perfusion Mismatch, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Ventilation Perfusion Mismatch, Pulmonary Edema
- What is being tested?
- Extravascular Lung Water Index and Pulmonary Vascular Permeability Index
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with ARDS in the adult ICU that have a TPTD catheter inserted since 2018 will be eligible for recruitment
Who may be able to join
- ARDS defined by Berlin Criteria longer than 24 hours
- Undergoing mechanical ventilation
- Noradrenaline demand >0.1 mcg/kg/min
Who cannot join
- Not meeting ARDS criteria
- Noninvasive mechanical ventilation
- ARDS resolved shorter than 24 hours
- Shock resolved
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Respiratory Distress Syndrome, Adult, Ventilation Perfusion Mismatch, Pulmonary Edema, Covid19
- Being tested
- Extravascular Lung Water Index, Pulmonary Vascular Permeability Index
- Keywords
- ards, covid19
- Medical subject headings
- Respiratory Distress Syndrome, Pulmonary Edema, COVID-19, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extravascular Lung Water IndexDevice
Measurement of the EVLWI
Pulmonary Vascular Permeability IndexDevice
Measurement of the PVPI
| Study group | Role | What they receive |
|---|---|---|
| Typical ARDS | ARDS due to non Covid19 causes Receives: Device: Extravascular Lung Water Index; Device: Pulmonary Vascular Permeability Index | |
| C-ARDS | ARDS due to Covid19 Receives: Device: Extravascular Lung Water Index; Device: Pulmonary Vascular Permeability Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extravascular Lung Water Index
The amount of fluid accumulated in the lung measured by transpulmonary thermodilution (ml/kg)
Measured: 1 day
Pulmonary vascular permeability index
Integrity of the alveolocapillary barrier measured by transpulmonary thermodilution
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olcay Dilken, Istanbul University - Cerrahpasa
- Investigators
- Yalım Dikmen, Prof, Study director, Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508933
- Sponsor's protocol ID
- 0308202247
- Status last verified
- Oct 2021
- First submitted
- 8 Aug 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data available on reasonable request
Publications
Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5.
PubMed 28625165
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
- ClinicalTrials.gov ID
- NCT04508933
- Acronym / sponsor ID
- 0308202247
- Conditions
- Respiratory Distress Syndrome, Adult, Ventilation Perfusion Mismatch, Pulmonary Edema, Covid19
- Keywords
- ards, covid19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typical ARDS | – | Device: Extravascular Lung Water Index, Device: Pulmonary Vascular Permeability IndexARDS due to non Covid19 causes |
| C-ARDS | – | Device: Extravascular Lung Water Index, Device: Pulmonary Vascular Permeability IndexARDS due to Covid19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with ARDS in the adult ICU that have a TPTD catheter inserted since 2018 will be eligible for recruitment
Key inclusion criteria (3 listed)
- ARDS defined by Berlin Criteria longer than 24 hours
- Undergoing mechanical ventilation
- Noradrenaline demand >0.1 mcg/kg/min
Key exclusion criteria (4 listed)
- Not meeting ARDS criteria
- Noninvasive mechanical ventilation
- ARDS resolved shorter than 24 hours
- Shock resolved
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extravascular Lung Water IndexMeasurement of the EVLWI | Device | C-ARDS, Typical ARDS |
| Pulmonary Vascular Permeability IndexMeasurement of the PVPI | Device | C-ARDS, Typical ARDS |
Primary outcome
Extravascular Lung Water Index
Time frame: 1 day
The amount of fluid accumulated in the lung measured by transpulmonary thermodilution (ml/kg)
Pulmonary vascular permeability index
Time frame: 1 day
Integrity of the alveolocapillary barrier measured by transpulmonary thermodilution
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Results publication: PubMed 28625165Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5.
- Individual participant dataSharing planned: Undecided. Data available on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yalım Dikmen, Prof study director
Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult and Ventilation Perfusion Mismatch, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extravascular Lung Water Index (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04508933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.