DehydrationMicroCircNCT04261374
Microcirculation in Dehydrated Older Patients
An observational study of Dehydration, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
This proof-of-concept study examines whether 1) sublingual measurement in dehydrated old patients is feasible, 2) frailty and incompliance in old, awake patients affects video-quality, 3) dehydration impacts microcirculation This prospective observational study includes clinically dehydrated patients aged ≥ 65 years… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dehydration
- What is being tested?
- Measurement of sublingual microcirculation
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2019to 1 Jun 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: Patients who clinically dehydrated
Who may be able to join
- 65 years old or older
- diagnosed with dehydration according to the clinical impression of the treating physician
- informed consent
- the sublingual mucosa had to be accessible.
Who cannot join
- <65 years
- Lacking informed consent
- time-critical disease
- previous resuscitation
- inaccessibility of sublingual area
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: The Analysis of the Sublingual Microvascular Terminal Circuit Improves the Diagnostic and Therapeutic Algorithms in Dehydrated Older Patients- a Prospective Observational Study
This proof-of-concept study examines whether 1) sublingual measurement in dehydrated old patients is feasible, 2) frailty and incompliance in old, awake patients affects video-quality, 3) dehydration impacts microcirculation This prospective observational study includes clinically dehydrated patients aged ≥ 65 years, who have spontaneous circulation and access to the sublingual mucosa, immediately after admission. Dehydration will be assessed clinically. A sidestream dark field camera (SDF) will be used for measurement. Video-quality will be evaluated with MIQS (microcirculation image quality score). Both AVA 4.3C- and AVA POEM-software analyzed the videos. Seventeen patients ≥ 65 years not showing dehydration served as control.
- Conditions
- Dehydration
- Being tested
- Measurement of sublingual microcirculation
- Keywords
- Microcirculation, dehydration, risk stratification
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of sublingual microcirculationDiagnostic test
Measurement of sublingual microcirculation
| Study group | Role | What they receive |
|---|---|---|
| Measurement of sublingual microcirculation | Not described Receives: Diagnostic Test: Measurement of sublingual microcirculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of Percentage of Perfusion Vessels [%]
Measurement of sublingual microcirculation by using MicroScan® microscope. AVA 4.3C calculates automatically important microcirculatory values (Percentage of Perfusion Vessels; DeBackerDensity; Perfused DeBackerDensity; Perfused Vessel Density) according to the Second Consensus Conference
Measured: at Baseline and after 24 hours
Secondary outcomes (5)
Microcirculatory quality score (MIQS)
MIQS by Massey et al. is an established method to validate recorded SDF-videos for their suitability for further analysis. MIQS assigns a score of optimal (0 points), suboptimal but acceptable (1 point), or unacceptable (10 points) to the categories illumination, duration, focus, content, stability, and pressure. The scoring will be done for every recorded video during the offline analysis
Measured: at Baseline
Clinical Frailty Scale
The Clinical Frailty Scale (CFS) is a simple model visually describing patients physical conditions with nine classes from very fit (class 1) to terminally ill (class 9)
Measured: at Baseline
Barthel scoring
Nursing status will be estimated by the Barthel-Index ranging from 100 points ("normal and autonomous") to 0 points ("completely depending from nursing").
Measured: at Baseline
Mini-Mental-Test scoring
The standardized Mini-Mental-Test 30 is a screening tool for cognitive impairment. The test will be performed directly before SDF-measurement. The best possible result is 30 points, the worst 0 points. Test results up to 24 points can be considered normal
Measured: at Baseline
Rate of mortality
30 days mortality will be assessed using the medical records of the hospital or direct contact to the patient.
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261374
- Sponsor's protocol ID
- 16-003
- Acronym
- MicroCirc
- Status last verified
- Jun 2020
- First submitted
- 29 Jan 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of the Sublingual Microvascular Terminal Circuit Improves the Diagnostic and Therapeutic Algorithms in Dehydrated Older Patients- a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04261374
- Acronym / sponsor ID
- MicroCirc / 16-003
- Conditions
- Dehydration
- Keywords
- Microcirculation, dehydration, risk stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 7 Feb 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.
This proof-of-concept study examines whether 1) sublingual measurement in dehydrated old patients is feasible, 2) frailty and incompliance in old, awake patients affects video-quality, 3) dehydration impacts microcirculation This prospective observational study includes clinically dehydrated patients aged ≥ 65 years, who have spontaneous circulation and access to the sublingual mucosa, immediately after admission. Dehydration will be assessed clinically. A sidestream dark field camera (SDF) will be used for measurement. Video-quality will be evaluated with MIQS (microcirculation image quality score). Both AVA 4.3C- and AVA POEM-software analyzed the videos. Seventeen patients ≥ 65 years not showing dehydration served as control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement of sublingual microcirculation | – | Diagnostic Test: Measurement of sublingual microcirculation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who clinically dehydrated
Key inclusion criteria (4 listed)
- 65 years old or older
- diagnosed with dehydration according to the clinical impression of the treating physician
- informed consent
- the sublingual mucosa had to be accessible.
Key exclusion criteria (5 listed)
- <65 years
- Lacking informed consent
- time-critical disease
- previous resuscitation
- inaccessibility of sublingual area
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 |
|---|---|---|
| Measurement of sublingual microcirculationMeasurement of sublingual microcirculation | Diagnostic test | Measurement of sublingual microcirculation |
Primary outcome
Change from Baseline of Percentage of Perfusion Vessels [%]
Time frame: at Baseline and after 24 hours
Measurement of sublingual microcirculation by using MicroScan® microscope. AVA 4.3C calculates automatically important microcirculatory values (Percentage of Perfusion Vessels; DeBackerDensity; Perfused DeBackerDensity; Perfused Vessel Density) according to the Second Consensus Conference
5 secondary outcomes
Microcirculatory quality score (MIQS)
Time frame: at Baseline
Clinical Frailty Scale
Time frame: at Baseline
Barthel scoring
Time frame: at Baseline
Mini-Mental-Test scoring
Time frame: at Baseline
Rate of mortality
Time frame: 30 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dehydration, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline of Percentage of Perfusion Vessels [%] (time frame: at Baseline and after 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2020.