Viewing Study NCT02296593


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Study NCT ID: NCT02296593
Status: COMPLETED
Last Update Posted: 2017-03-07
First Post: 2014-11-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Continuous MONItoring of Blood LActate and Glucose Levels Using a New Central Veinous Microdialysis Catheter Device
Sponsor: University Hospital, Caen
Organization:

Study Overview

Official Title: Monitorage Continu du Lactate et de la glycémie Par Microdialyse : Une étude de Validation en Chirurgie Cardiaque.
Status: COMPLETED
Status Verified Date: 2017-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MONILAG
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: