- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02296593
Continuous MONItoring of Blood LActate and Glucose Levels Using a New Central Veinous Microdialysis Catheter Device (MONILAG)
Monitorage Continu du Lactate et de la glycémie Par Microdialyse : Une étude de Validation en Chirurgie Cardiaque.
Study Overview
Status
Intervention / Treatment
Detailed Description
MAQUET Group offers a new device that gives real time blood lactate and glucose levels. It is a new central veinous catheter with a microdialysis system. It is planted in the superior vena cava. It has not yet been used and validated with a clinical purpose, and particularly in cardiac surgery.
For now, reference method for determining blood lactate and glucose levels is co oxymetry.
This new simple device could provide great fluency for determining blood lactate and glucose levels. It could allow medical teams gain time for diagnosis and treatment of both hyperlactatemia and hyperglycemia.
The primary outcome of this study was to compare blood lactate and glucose absolute measures provided with the MAQUET new device (Maquet Critical Care AB, Solna, Sweden) and with co oxymetry.
The secondary outcome of this study was to compare variations of these absolutes measures.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Basse Normandie
-
Caen, Basse Normandie, France, 14000
- CHU de Caen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men or women more than 18 years old.
- Cardiac surgery.
- Central veinous catheter in superior vena cava.
Exclusion Criteria:
- Men or women less than 18 years old.
- Pregnant women.
- Central veinous catheter not in superior vena cava.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comparison of absolute blood lactate and glucose levels with the reference method (co oxymetry) and a new method using a device providing real time measures of lactate and glycemia with a central veinous catheter microdialysis system.
Time Frame: 1 day
|
Central veinous catheter, EIRUS (Maquet Critical Care AB, Solna, Sweden)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comparison of variations of blood lactate and glycemia levels with the reference method (co oxymetry) and a new method using a device providing real time measures of lactate and glycemia. (EIRUS) with a central veinous catheter microdialysis system.
Time Frame: 1 day
|
Central veinous catheter, EIRUS (Maquet Critical Care AB, Solna, Sweden)
|
1 day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- A14-D36-VOL.22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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