Microcirculation in Dehydrated Older Patients

Completed

• Conditions: Dehydration

• Registration Number: NCT04261374
• Lead Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Status Verified: 2020-06
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline of Percentage of Perfusion Vessels [%]	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 Outcome Measures

Name	Time	Method
Microcirculatory quality score (MIQS)	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
Mini-Mental-Test scoring	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
Barthel scoring	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").
Rate of mortality	30 days after discharge	30 days mortality will be assessed using the medical records of the hospital or direct contact to the patient.
Clinical Frailty Scale	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)

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Duesseldorf, Germany