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Microcirculation in Dehydrated Older Patients

The Analysis of the Sublingual Microvascular Terminal Circuit Improves the Diagnostic and Therapeutic Algorithms in Dehydrated Older Patients- a Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04261374
Acronym
MicroCirc
Enrollment
13
Registered
2020-02-07
Start date
2019-06-01
Completion date
2020-06-01
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration

Keywords

Microcirculation, dehydration, risk stratification

Brief 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, 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.

Interventions

Measurement of sublingual microcirculation

Sponsors

Klinik für Kardiologie, Pneumologie und Angiologie
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* \<65 years * Lacking informed consent * time-critical disease * previous resuscitation * inaccessibility of sublingual area

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline of Percentage of Perfusion Vessels [%]at Baseline and after 24 hoursMeasurement 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

Secondary

MeasureTime frameDescription
Microcirculatory quality score (MIQS)at BaselineMIQS 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
Clinical Frailty Scaleat BaselineThe 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)
Barthel scoringat BaselineNursing status will be estimated by the Barthel-Index ranging from 100 points (normal and autonomous) to 0 points (completely depending from nursing).
Mini-Mental-Test scoringat BaselineThe 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
Rate of mortality30 days after discharge30 days mortality will be assessed using the medical records of the hospital or direct contact to the patient.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026