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.
1 other identifier
observational
20
1 country
1
Brief Summary
Continuous lactate and glucose blood levels
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 Nov 2014
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
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 18, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMarch 7, 2017
March 1, 2017
1.5 years
November 18, 2014
March 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Central veinous catheter, EIRUS (Maquet Critical Care AB, Solna, Sweden)
1 day
Secondary Outcomes (1)
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.
1 day
Interventions
comparison of blood lactate and glucose levels with the reference method (co oxymetry) and a new central veinous catheter microdialysis system provided by MAQUET. (Critical Care AB, Solna, Sweden.)
Eligibility Criteria
Consecutive patients of cardiac surgery. (planned or for emergencies)
You may qualify if:
- Men or women more than 18 years old.
- Cardiac surgery.
- Central veinous catheter in superior vena cava.
You may not qualify if:
- Men or women less than 18 years old.
- Pregnant women.
- Central veinous catheter not in superior vena cava.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Caen
Caen, Basse Normandie, 14000, France
Related Publications (1)
Gouezel C, Lorne E, Bonnet V, Fradin S, Saplacan V, Gerard JL, Hanouz JL, Fellahi JL, Fischer MO; FHT (French Hemodynamic Team). Assessment of changes in lactate concentration with intravascular microdialysis during high-risk cardiac surgery using the trend interchangeability method. Br J Anaesth. 2017 Dec 1;119(6):1110-1117. doi: 10.1093/bja/aex338.
PMID: 29028910DERIVED
Biospecimen
Blood samples for determination of lactate and glucose blood levels
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2014
First Posted
November 20, 2014
Study Start
November 1, 2014
Primary Completion
May 1, 2016
Study Completion
November 1, 2016
Last Updated
March 7, 2017
Record last verified: 2017-03