Extracellular Fluid AlterationNCT04416009
Extracellular Water in Covid 19 Pneumonia
An observational study of Extracellular Fluid Alteration and Corona Virus Infection, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
According to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Based on this similarity, extracellular fluid of lungs and diffuse alveolar damage should be observed in covid 19 pneumonia as well. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extracellular Fluid Alteration, Corona Virus Infection
- What is being tested?
- NİCaS
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2020to 20 Feb 2021
- How long will I take part?
- 1 Day
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized covid 19 patients
Who may be able to join
- Covid 19 pneumonia, hospitalized patients older than 18
Who cannot join
- younger than 18 years old, patients not infected with covid 19
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpaşa TREH
Istanbul, Gaziosmanpaşa, 34255
zuhal çavuş, MD, +902129453000 ext. 1436, zuhalcavus74@gmail.com
aygen türkmen, Prof.MD, +902129453000 ext. 1641, aygenturkmen@hotmail.com
About this study
Official title: the Determination of Extracellular Water (ECW) Which is Detected by Bioimpedence Method on Severe and Mild Covid 19 Pneumonia Clinical Course
According to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Based on this similarity, extracellular fluid of lungs and diffuse alveolar damage should be observed in covid 19 pneumonia as well. Extracellular water (ECW) can be determine by using whole body bioimpedence system (NİCaS). The aim of this study is to investigate the effect of ECW on the clinical apperence of covid 19 pneumonia clinical course.
Read the detailed description
Increase in the extracellular water of lungs is the major pathophisilogy of ARDS. According to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Depending on the similarity of Covid 19 and ARDS; evaluation of ECW ,can be a determinant of clinical apperence of covid19 pneumonia. The aim of this study to find the corelation between ECW and severty of the pneumonia.
In this prospective -controlled research, the patients who were diagnosed with Covid-19 pneumonia will be evaluated. The ones in the intensive care will be considered as severe, and the ones in the ward will be considered as mild clinical course pneumonia. İn both groups, in addition to other heamodynamic parametres, ECW will be recorded using non-invasive body biooimpedence method by NİCaS machine. The total amount of patients will be 52, 26 each two groups.
The ward and intensive care patients will be connected to the NİCaS machine to determine ECW and statistically significantchanges will be recorded. The device consists of a laptop, a software which calculates cardiac parameters and two electrodes. The measurement is done by the following process: one of these electrodes, which looks like ECG electrodes, is stuck to the wrist and the other one to the opposite ankle or each one to two wrists.
the severety of illness will try to be detected.Gpower 3 for Mac Os (Faul, F., Erdfelder, E., Buchner, A., \& Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 11491160.) was used for istatistical power analysis.The power analysis was done priorly and based on the T-test.In order to provide enoughsample magnitude power, which is 0.8, it was calculated that each group should have 26 patients which makes at total of 52 Statistical method: The normal distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric ones will be used in normal distrubitions, non-parametric ones will be used in abnormal distrubitions. İntergroup ECW values will be compared via independent sample T test. In catagoric data, the comparisons will be made with Pearson Ki square test, and the p values less then 0.05 will be considered as significant.
- Being tested
- NİCaS
- Keywords
- covid-19, NİCaS, pneumonia
- Medical subject headings
- Coronavirus Infections, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NİCaSDevice
whole body bioimpedence method
| Study group | Role | What they receive |
|---|---|---|
| mild pneumonia ECW | the covid 19 pneumonia patients who hospitalised to the ward Receives: Device: NİCaS | |
| severe pneumonia ECW | the covid 19 pneumonia patients who hospitalised to the intensive care unit Receives: Device: NİCaS |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECW
Changes of three measurements of extracellular water in both lungs
Measured: three measurements with half an hour intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start5 Jul 2020 (estimated)
- Primary completion20 Dec 2020 (estimated)
- Study completion20 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Extracellular Fluid AlterationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SİBEL BEKTAŞ, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416009
- Sponsor's protocol ID
- 76
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tagami T, Ong MEH. Extravascular lung water measurements in acute respiratory distress syndrome: why, how, and when? Curr Opin Crit Care. 2018 Jun;24(3):209-215. doi: 10.1097/MCC.0000000000000503.
PubMed 29608455Jozwiak M, Teboul JL, Monnet X. Extravascular lung water in critical care: recent advances and clinical applications. Ann Intensive Care. 2015 Dec;5(1):38. doi: 10.1186/s13613-015-0081-9. Epub 2015 Nov 6.
PubMed 26546321
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Determination of Extracellular Water (ECW) Which is Detected by Bioimpedence Method on Severe and Mild Covid 19 Pneumonia Clinical Course
- ClinicalTrials.gov ID
- NCT04416009
- Acronym / sponsor ID
- 76
- Keywords
- covid-19, NİCaS, pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 5 Jul 2020 (estimated)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 20 Feb 2021 (estimated)
- First posted
- 4 Jun 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.
According to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Based on this similarity, extracellular fluid of lungs and diffuse alveolar damage should be observed in covid 19 pneumonia as well. Extracellular water (ECW) can be determine by using whole body bioimpedence system (NİCaS). The aim of this study is to investigate the effect of ECW on the clinical apperence of covid 19 pneumonia clinical course.
Detailed description
Increase in the extracellular water of lungs is the major pathophisilogy of ARDS. According to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Depending on the similarity of Covid 19 and ARDS; evaluation of ECW ,can be a determinant of clinical apperence of covid19 pneumonia. The aim of this study to find the corelation between ECW and severty of the pneumonia.
In this prospective -controlled research, the patients who were diagnosed with Covid-19 pneumonia will be evaluated. The ones in the intensive care will be considered as severe, and the ones in the ward will be considered as mild clinical course pneumonia. İn both groups, in addition to other heamodynamic parametres, ECW will be recorded using non-invasive body biooimpedence method by NİCaS machine. The total amount of patients will be 52, 26 each two groups.
The ward and intensive care patients will be connected to the NİCaS machine to determine ECW and statistically significantchanges will be recorded. The device consists of a laptop, a software which calculates cardiac parameters and two electrodes. The measurement is done by the following process: one of these electrodes, which looks like ECG electrodes, is stuck to the wrist and the other one to the opposite ankle or each one to two wrists.
the severety of illness will try to be detected.Gpower 3 for Mac Os (Faul, F., Erdfelder, E., Buchner, A., \& Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 11491160.) was used for istatistical power analysis.The power analysis was done priorly and based on the T-test.In order to provide enoughsample magnitude power, which is 0.8, it was calculated that each group should have 26 patients which makes at total of 52 Statistical method: The normal distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric ones will be used in normal distrubitions, non-parametric ones will be used in abnormal distrubitions. İntergroup ECW values will be compared via independent sample T test. In catagoric data, the comparisons will be made with Pearson Ki square test, and the p values less then 0.05 will be considered as significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild pneumonia ECW | – | Device: NİCaSthe covid 19 pneumonia patients who hospitalised to the ward |
| severe pneumonia ECW | – | Device: NİCaSthe covid 19 pneumonia patients who hospitalised to the intensive care unit |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized covid 19 patients
Key inclusion criteria (1 listed)
- Covid 19 pneumonia, hospitalized patients older than 18
Key exclusion criteria (1 listed)
- younger than 18 years old, patients not infected with covid 19
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 |
|---|---|---|
| NİCaSwhole body bioimpedence method | Device | mild pneumonia ECW, severe pneumonia ECW |
Primary outcome
ECW
Time frame: three measurements with half an hour intervals
Changes of three measurements of extracellular water in both lungs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 29608455Tagami T, Ong MEH. Extravascular lung water measurements in acute respiratory distress syndrome: why, how, and when? Curr Opin Crit Care. 2018 Jun;24(3):209-215. doi: 10.1097/MCC.0000000000000503.
- Background: PubMed 26546321Jozwiak M, Teboul JL, Monnet X. Extravascular lung water in critical care: recent advances and clinical applications. Ann Intensive Care. 2015 Dec;5(1):38. doi: 10.1186/s13613-015-0081-9. Epub 2015 Nov 6.
- Individual participant dataSharing planned: No
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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.
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 Extracellular Fluid Alteration and Corona Virus Infection, run by Gaziosmanpasa Research and Education Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECW (time frame: three measurements with half an hour intervals). 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 NCT04416009, which also lists 2 linked publications.
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 4 Jun 2020.