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
1 other identifier
observational
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 29, 2020
CompletedFirst Posted
Study publicly available on registry
February 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 18, 2020
June 1, 2020
1 year
January 29, 2020
June 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Microcirculatory quality score (MIQS)
at Baseline
Clinical Frailty Scale
at Baseline
Barthel scoring
at Baseline
Mini-Mental-Test scoring
at Baseline
Rate of mortality
30 days after discharge
Study Arms (1)
Measurement of sublingual microcirculation
Interventions
Measurement of sublingual microcirculation
Eligibility Criteria
Patients who clinically dehydrated
You may qualify if:
- 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.
You may not qualify if:
- \<65 years
- Lacking informed consent
- time-critical disease
- previous resuscitation
- inaccessibility of sublingual area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
January 29, 2020
First Posted
February 7, 2020
Study Start
June 1, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
June 18, 2020
Record last verified: 2020-06