Microcirculation in Dehydrated Older Patients (MicroCirc)

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.

Study Overview

• Status: Completed
• Conditions: Dehydration
• Intervention / Treatment: Diagnostic test: Measurement of sublingual microcirculation

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• Germany
  • Duesseldorf, Germany, 40225
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who clinically dehydrated

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Measurement of sublingual microcirculation	Diagnostic test: Measurement of sublingual microcirculation; Measurement of sublingual microcirculation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (ACTUAL): February 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Microcirculation; dehydration; risk stratification
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: 16-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No