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OpenTrials
Completed

NCT Number: NCT02296593

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

Continuous lactate and glucose blood levels

Completed

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Key information

Conditions

Other Functional Disturbances Following Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Caen

Caen, Basse Normandie, 14000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

comparison of blood lactate and glucose levels

Device

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.)

Other names: EIRUS, continuous lactate monitoring, continuous glycemia monitoring, central veinous catheter, microdialysis system, MAQUET

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.

    Time frame: 1 day

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

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.

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Monitorage Continu du Lactate et de la glycémie Par Microdialyse : Une étude de Validation en Chirurgie Cardiaque.

Acronym: MONILAG

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2014
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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