Study of the Impact of Changes in Carbonemia on Microcirculation in Patients Achieving a Test Hypercapnia
1 other identifier
interventional
10
1 country
1
Brief Summary
The microcirculatory alterations is common in circulatory failure, especially during sepsis. The severity of these changes and their sustainability are responsible of multi organ failure and ultimately death. The optimization of microcirculatory flow could be a central objective of the management of patients hospitalized in intensive care. Microcirculation includes all blood vessels of a diameter smaller than 100 micrometer. It represents the largest heat exchange surface of the body and is involved in tissue oxygenation. Microcirculatory flow is conditioned by the macrocirculation (heart rate and blood pressure) and the state of the microcirculation (thrombosis, vasoconstriction ...). The role of the CO2 in regulating microcirculatory flow is little studied. A recent work of our team and the oldest work in the literature lead to believe that CO2 has a specific role in modulating microcirculatory flow. No study to date precisely studied the impact of changes in the microcirculatory flow carbonemia . The hypocapnia test is carried out in a standardized manner by inhalation of a mixture enriched in CO2 7% allows a significant increase in carbonemia. Hypocapnia will in turn obtained by a calibrated voluntary hyperventilation test. Direct visualization of microcirculation by confocal microscopy is now considered the gold standard for exploring the microcirculation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 11, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedSeptember 15, 2015
September 1, 2015
1 month
September 11, 2015
September 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
microcirculatory flow (cells / min) measured by confocal microscopy
microcirculatory flow (cells / min) measured by confocal microscopy in hypocapnic patients
Day1
Secondary Outcomes (1)
microvessel diameter (micrometer) measured by confocal microscopy
Day1
Study Arms (1)
patients with a hypercapnia test
EXPERIMENTALconfocal microscopy patients with a hypercapnia test
Interventions
microvessel diameter measured by confocal microscopy
Eligibility Criteria
You may qualify if:
- patients from achieving hypercapnia test the CHU of Saint-Etienne
- non smoking
- non diabetic
- affiliated with or entitled to a social security system
- Written consent
You may not qualify if:
- subjects not performing the test hypercapnia in full
- patients with dermatological pathology at the study area
- patient with Raynaud's syndrome
- Patients with known bleeding disorders
- refusal to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Saint-Etienne
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Gergelé, MD
CHU SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2015
First Posted
September 15, 2015
Study Start
May 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 15, 2015
Record last verified: 2015-09