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Completed

NCT Number: NCT04261374

Microcirculation in Dehydrated Older Patients

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.

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Key information

Conditions

Dehydration Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of sublingual microcirculation

Diagnostic Test

Measurement of sublingual microcirculation

Primary outcomes

  1. 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

Secondary outcomes

  1. Microcirculatory quality score (MIQS)

    Time frame: at Baseline

    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

  2. Clinical Frailty Scale

    Time frame: at Baseline

    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)

  3. Barthel scoring

    Time frame: at Baseline

    Nursing status will be estimated by the Barthel-Index ranging from 100 points ("normal and autonomous") to 0 points ("completely depending from nursing").

  4. Mini-Mental-Test scoring

    Time frame: at Baseline

    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

  5. Rate of mortality

    Time frame: 30 days after discharge

    30 days mortality will be assessed using the medical records of the hospital or direct contact to the patient.

Sponsors and collaborators

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Other

Registry information

Official study title

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

Acronym: MicroCirc

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2020
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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