Continuous MONItoring of Blood LActate and Glucose Levels Using a New Central Veinous Microdialysis Catheter Device

Completed

• Conditions: Other Functional Disturbances Following Cardiac Surgery

• Registration Number: NCT02296593
• Lead Sponsor: University Hospital, Caen

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-20
• Primary Completion: 2016-05
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	1 day	Central veinous catheter, EIRUS (Maquet Critical Care AB, Solna, Sweden)

Secondary Outcome Measures

Name	Time	Method
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	Central veinous catheter, EIRUS (Maquet Critical Care AB, Solna, Sweden)

Trial Locations

Locations (1)

CHU de Caen; 🇫🇷 Caen, Basse Normandie, France