Other Functional Disturbances Following Cardiac SurgeryMONILAGNCT02296593
Continuous MONItoring of Blood LActate and Glucose Levels Using a New Central Veinous Microdialysis Catheter Device
An observational study of Other Functional Disturbances Following Cardiac Surgery, run by University Hospital, Caen at 1 site in France.
Trial summary
Continuous lactate and glucose blood levels Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Functional Disturbances Following Cardiac Surgery
- What is being tested?
- comparison of blood lactate and glucose levels
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients of cardiac surgery. (planned or for emergencies)
Who may be able to join
- Men or women more than 18 years old.
- Cardiac surgery.
- Central veinous catheter in superior vena cava.
Who cannot join
- Men or women less than 18 years old.
- Pregnant women.
- Central veinous catheter not in superior vena cava.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitorage Continu du Lactate et de la glycémie Par Microdialyse : Une étude de Validation en Chirurgie Cardiaque.
Continuous lactate and glucose blood levels
Read the 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.
- Being tested
- comparison of blood lactate and glucose levels
- Keywords
- lactate, continuous lactate monitoring, continuous blood glucose monitoring, EIRUS, blood glucose, cardiac surgery, central veinous catheter, microdialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of blood lactate and glucose levelsDevice
Also called EIRUS, continuous lactate monitoring, continuous glycemia monitoring, central veinous catheter
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.)
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Central veinous catheter, EIRUS (Maquet Critical Care AB, Solna, Sweden)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Functional Disturbances Following Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296593
- Sponsor's protocol ID
- A14-D36-VOL.22
- Acronym
- MONILAG
- Status last verified
- Mar 2017
- First submitted
- 18 Nov 2014
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29028910
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitorage Continu du Lactate et de la glycémie Par Microdialyse : Une étude de Validation en Chirurgie Cardiaque.
- ClinicalTrials.gov ID
- NCT02296593
- Acronym / sponsor ID
- MONILAG / A14-D36-VOL.22
- Keywords
- lactate, continuous lactate monitoring, continuous blood glucose monitoring, EIRUS, blood glucose, cardiac surgery, central veinous catheter, microdialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients of cardiac surgery. (planned or for emergencies)
Key inclusion criteria (3 listed)
- Men or women more than 18 years old.
- Cardiac surgery.
- Central veinous catheter in superior vena cava.
Key exclusion criteria (3 listed)
- Men or women less than 18 years old.
- Pregnant women.
- Central veinous catheter not in superior vena cava.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparison of blood lactate and glucose levelsAlso: EIRUS, continuous lactate monitoring, continuous glycemia monitoring, central veinous cathetercomparison 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.) | Device | – |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Derived from this study: PubMed 29028910Gouezel 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Functional Disturbances Following Cardiac Surgery, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02296593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.