Microcirculation in Dehydrated Older Patients

Dehydration Clinical Trial

— MicroCirc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261374
• Other study ID #: 16-003
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dehydration

Intervention

Diagnostic Test:
• Measurement of sublingual microcirculation
Measurement of sublingual microcirculation

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at Baseline and after 24 hours
Secondary	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	at Baseline
Secondary	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)	at Baseline
Secondary	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").	at Baseline
Secondary	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	at Baseline
Secondary	Rate of mortality	30 days mortality will be assessed using the medical records of the hospital or direct contact to the patient.	30 days after discharge