ShockNCT03464747
Continuous Central Venous Lactate Monitoring by Intravascular Microdialysis : a Comparison to Sequential Arterial Lactate Measurement During Shock.
An observational study of Shock, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
During shock, arterial hypotension, inadequate cardiac output and microcirculatory alterations lead to tissue hypoxia, multiple organ failure and death. Arterial lactate is considered as the best marker of tissue hypoxia. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Shock
- What is being tested?
- EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden)
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2017to 15 Jun 2018
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients
Who may be able to join
- Acute circulatory failure defined as : systolic blood pressure<90mmHg or mean arterial pressure <65mmHg and blood lactate > 2mmol/L
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
During shock, arterial hypotension, inadequate cardiac output and microcirculatory alterations lead to tissue hypoxia, multiple organ failure and death. Arterial lactate is considered as the best marker of tissue hypoxia. A lactate decrease during the first 6 hour is strongly associated with better outcome and may be used as a target for assessing the efficiency of shock resuscitation.
The EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden) is a new device allowing the continuous measurement of venous lactate through a central venous catheter.
However, before being used extensively, such device needs to be evaluated concerning its accuracy. The aim of the present study is to assess the reliability of this device.
- Conditions
- Shock
- Being tested
- EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden)
- Keywords
- Lactic Acid
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden)Device
continuous measurement of venous lactate through a central venous catheter by microdialysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement
Agreement between sequential arterial blood lactate measurement and continuous venous lactate obtained by microdialysis
Measured: Every 4hours for 48hours
Secondary outcomes (1)
Interchangeability
Interchangeability of the variations of the two methods using the trend interchangeability method
Measured: Every 4hours for 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start17 Feb 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464747
- Sponsor's protocol ID
- IRB : 16.09.02
- Status last verified
- Aug 2020
- First submitted
- 8 Mar 2018
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Central Venous Lactate Monitoring by Intravascular Microdialysis : a Comparison to Sequential Arterial Lactate Measurement During Shock.
- ClinicalTrials.gov ID
- NCT03464747
- Acronym / sponsor ID
- IRB : 16.09.02
- Conditions
- Shock
- Keywords
- Lactic Acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 14 Mar 2018 (actual)
- 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.
During shock, arterial hypotension, inadequate cardiac output and microcirculatory alterations lead to tissue hypoxia, multiple organ failure and death. Arterial lactate is considered as the best marker of tissue hypoxia. A lactate decrease during the first 6 hour is strongly associated with better outcome and may be used as a target for assessing the efficiency of shock resuscitation.
The EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden) is a new device allowing the continuous measurement of venous lactate through a central venous catheter.
However, before being used extensively, such device needs to be evaluated concerning its accuracy. The aim of the present study is to assess the reliability of this device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (1 listed)
- Acute circulatory failure defined as : systolic blood pressure<90mmHg or mean arterial pressure <65mmHg and blood lactate > 2mmol/L
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden)continuous measurement of venous lactate through a central venous catheter by microdialysis | Device | – |
Primary outcome
Agreement
Time frame: Every 4hours for 48hours
Agreement between sequential arterial blood lactate measurement and continuous venous lactate obtained by microdialysis
1 secondary outcome
Interchangeability
Time frame: Every 4hours for 48hours
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 12 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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 Shock, run by Centre Hospitalier Universitaire de Nīmes 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 1 inclusion and 0 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 12 Aug 2020. 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?
Agreement (time frame: Every 4hours for 48hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.