Clinical trial NCT02296593: Continuous MONItoring of Blood LActate and Glucose Levels Using a New Central Veinous Microdialysis Catheter Device
Official title: Monitorage Continu du Lactate et de la glycémie Par Microdialyse : Une étude de Validation en Chirurgie Cardiaque.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Functional Disturbances Following Cardiac Surgery
Keywords: lactate
continuous lactate monitoring
continuous blood glucose monitoring
EIRUS
blood glucose
cardiac surgery
central veinous catheter
microdialysis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients of cardiac surgery. (planned or for emergencies)

Brief summary: Continuous lactate and glucose blood levels

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 day
Secondary outcomes:
measure: 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.
timeFrame: 1 day
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
state: Basse Normandie
Study officials:
References:
citation: 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.