HyperlactatemiaPhase 4LACTELNCT05032521
Treatment of Hyperlactatemia in Acute Circulatory Failure Based on Analysis of CO2: a Prospective Randomized Superiority Study (The LACTEL Study)
A Phase 4 study testing collection of biological data, collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data and Standard treatment in people with Hyperlactatemia and Actue Circulatory Failure, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The management of a patient with shock is based on improving tissue oxygenation through hemodynamic optimization. Lactate is a marker of tissue hypoperfusion commonly used in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlactatemia, Actue Circulatory Failure
- What is being tested?
- collection of biological data, collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data and Standard treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2021to 30 Nov 2023
- Phase
- Phase 4
- 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
Who may be able to join
- Oral, free and informed consent obtained from a trusted person (health care proxy) or a close relative or consent in an emergency situation
- Adult patient managed in intensive care for whom the physician has decided on hemodynamic management because of signs of acute circulatory failure (systolic blood pressure < 90 mmHg, mean arterial pressure < 65 mmHg, or the need for infusion of vasopressors, skin mottling, diuresis < 0.5 mL/kg/h for a duration ≥ 2 hours, skin recoloring time > 3 sec
- Arterial lactate level ≥ 3 mmol L-1
Who cannot join
- Person not affiliated to national health insurance
- Person subject to a measure of legal protection (curatorship, guardianship)
- Person subject to limited judicial protection
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
The management of a patient with shock is based on improving tissue oxygenation through hemodynamic optimization. Lactate is a marker of tissue hypoperfusion commonly used in the ICU. In principle, hyperlactatemia can be caused by either increased tissue production (tissue hypoperfusion: type A), decreased lactate uptake (type B), or a combination of both mechanisms. It is important to correctly determine the cause(s) of hyperlactatemia, as this determines the treatment (expanders, inotrope, vasopressor, blood derivative transfusion), and the patient's morbidity and mortality. A classic example of this concept is volume expanders, which are frequently used to correct hyperlactatemia secondary to tissue hypoperfusion, but are associated with mortality if used excessively (fluid overload). In clinical practice, it is difficult to differentiate the exact causes of hyperlactatemia (type A and type B). From work carried out over the last 20 years in septic shock and then in other states of shock and in the operating theatre, it has been shown that the arteriovenous CO2 gradient (pCO2gap) measured from arterial and venous blood gases is a marker of tissue hypoperfusion with better predictive ability than the usual markers (clinical examination, SVO2....). Furthermore, when we relate pCO2gap to the arteriovenous O2 difference (pCO2gap /C(a-v)O2), this ratio allows us to distinguish with greater accuracy between states of acute circulatory failure associated with anaerobiosis (tissue hypoperfusion, type A) and those related to the underlying disease.
Also, several studies have demonstrated a strong ability of the pCO2gap and the pCO2gap/CavO2 ratio to predict the severity of shock, mortality of the shock patient, hyperlactatemia, and correction of hyperlactatemia with hemodynamic treatment. As a result, many authors have proposed algorithms for the management of shock patients based on the measurement of these CO2-derived indexes.
The hypothesis of this study is that the use of an algorithm based on CO2gap and the CO2gap/CavO2 ratio is superior in terms of correction of hyperlactatemia to usual practice based on clinical and macro-hemodynamics.
- Conditions
- Hyperlactatemia, Actue Circulatory Failure
- Being tested
- collection of biological data, collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data, Standard treatment, stratified treatment according to algorithm
- Medical subject headings
- Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of biological dataBiological
collection of biological data
collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas dataOther
These data are usually measured continuously (monitoring of the resuscitation patient) and recorded on recorded on the resuscitation software.
Standard treatmentProcedure or surgery
usual management based on the use of drugs according to international recommendations
stratified treatment according to algorithmProcedure or surgery
management based on arteriovenous CO2 gradient Stratification of drug use
| Study group | Role | What they receive |
|---|---|---|
| standard practice | Active comparator | Not described Receives: Biological: collection of biological data; Other: collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data; Procedure: Standard treatment |
| algorithm | Experimental | Not described Receives: Biological: collection of biological data; Other: collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data; Procedure: stratified treatment according to algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the number of patients with a lactate clearance of more than 10% (change of more than 10% between baseline and the level measured at 2 hours after management) at H2.
Measured: 2 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start2 Nov 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperlactatemiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032521
- Sponsor's protocol ID
- GUINOT 2021-3
- Acronym
- LACTEL
- Status last verified
- Jan 2026
- First submitted
- 27 Aug 2021
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guinot PG, Evezard C, Nguyen M, Pili-Floury S, Berthoud V, Besch G, Bouhemad B; Lactel Study Group. Treatment of Acute Circulatory Failure Based on Carbon Dioxide-Oxygen (CO2-O2) Derived Indices: The Lactel Randomized Multicenter Study. Chest. 2025 Apr;167(4):1068-1078. doi: 10.1016/j.chest.2024.11.021. Epub 2024 Nov 28.
PubMed 39615831Caruso V, Besch G, Nguyen M, Pili-Floury S, Bouhemad B, Guinot PG; Lactel Study Group. Treatment of Hyperlactatemia in Acute Circulatory Failure Based on CO2-O2-Derived Indices: Study Protocol for a Prospective, Multicentric, Single, Blind, Randomized, Superiority Study (The LACTEL Study). Front Cardiovasc Med. 2022 Jun 23;9:898406. doi: 10.3389/fcvm.2022.898406. eCollection 2022.
PubMed 35811716
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hyperlactatemia in Acute Circulatory Failure Based on Analysis of CO2: a Prospective Randomized Superiority Study (The LACTEL Study)
- ClinicalTrials.gov ID
- NCT05032521
- Acronym / sponsor ID
- LACTEL / GUINOT 2021-3
- Conditions
- Hyperlactatemia, Actue Circulatory Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 2 Sep 2021 (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.
The management of a patient with shock is based on improving tissue oxygenation through hemodynamic optimization. Lactate is a marker of tissue hypoperfusion commonly used in the ICU. In principle, hyperlactatemia can be caused by either increased tissue production (tissue hypoperfusion: type A), decreased lactate uptake (type B), or a combination of both mechanisms. It is important to correctly determine the cause(s) of hyperlactatemia, as this determines the treatment (expanders, inotrope, vasopressor, blood derivative transfusion), and the patient's morbidity and mortality. A classic example of this concept is volume expanders, which are frequently used to correct hyperlactatemia secondary to tissue hypoperfusion, but are associated with mortality if used excessively (fluid overload). In clinical practice, it is difficult to differentiate the exact causes of hyperlactatemia (type A and type B). From work carried out over the last 20 years in septic shock and then in other states of shock and in the operating theatre, it has been shown that the arteriovenous CO2 gradient (pCO2gap) measured from arterial and venous blood gases is a marker of tissue hypoperfusion with better predictive ability than the usual markers (clinical examination, SVO2....). Furthermore, when we relate pCO2gap to the arteriovenous O2 difference (pCO2gap /C(a-v)O2), this ratio allows us to distinguish with greater accuracy between states of acute circulatory failure associated with anaerobiosis (tissue hypoperfusion, type A) and those related to the underlying disease.
Also, several studies have demonstrated a strong ability of the pCO2gap and the pCO2gap/CavO2 ratio to predict the severity of shock, mortality of the shock patient, hyperlactatemia, and correction of hyperlactatemia with hemodynamic treatment. As a result, many authors have proposed algorithms for the management of shock patients based on the measurement of these CO2-derived indexes.
The hypothesis of this study is that the use of an algorithm based on CO2gap and the CO2gap/CavO2 ratio is superior in terms of correction of hyperlactatemia to usual practice based on clinical and macro-hemodynamics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard practice | Active comparator | Biological: collection of biological data, Other: collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data, Procedure: Standard treatment |
| algorithm | Experimental | Biological: collection of biological data, Other: collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data, Procedure: stratified treatment according to algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Oral, free and informed consent obtained from a trusted person (health care proxy) or a close relative or consent in an emergency situation
- Adult patient managed in intensive care for whom the physician has decided on hemodynamic management because of signs of acute circulatory failure (systolic blood pressure < 90 mmHg, mean arterial pressure < 65 mmHg, or the need for infusion of vasopressors, skin mottling, diuresis < 0.5 mL/kg/h for a duration ≥ 2 hours, skin recoloring time > 3 sec
- Arterial lactate level ≥ 3 mmol L-1
Key exclusion criteria (4 listed)
- Person not affiliated to national health insurance
- Person subject to a measure of legal protection (curatorship, guardianship)
- Person subject to limited judicial protection
- Pregnancy or breastfeeding
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 |
|---|---|---|
| collection of biological datacollection of biological data | Biological | algorithm, standard practice |
| collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas dataThese data are usually measured continuously (monitoring of the resuscitation patient) and recorded on recorded on the resuscitation software. | Other | algorithm, standard practice |
| Standard treatmentusual management based on the use of drugs according to international recommendations | Procedure or surgery | standard practice |
| stratified treatment according to algorithmmanagement based on arteriovenous CO2 gradient Stratification of drug use | Procedure or surgery | algorithm |
Primary outcome
The primary endpoint is the number of patients with a lactate clearance of more than 10% (change of more than 10% between baseline and the level measured at 2 hours after management) at H2.
Time frame: 2 hours after inclusion
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 29 Jan 2026.
- Results publication: PubMed 39615831Guinot PG, Evezard C, Nguyen M, Pili-Floury S, Berthoud V, Besch G, Bouhemad B; Lactel Study Group. Treatment of Acute Circulatory Failure Based on Carbon Dioxide-Oxygen (CO2-O2) Derived Indices: The Lactel Randomized Multicenter Study. Chest. 2025 Apr;167(4):1068-1078. doi: 10.1016/j.chest.2024.11.021. Epub 2024 Nov 28.
- Derived from this study: PubMed 35811716Caruso V, Besch G, Nguyen M, Pili-Floury S, Bouhemad B, Guinot PG; Lactel Study Group. Treatment of Hyperlactatemia in Acute Circulatory Failure Based on CO2-O2-Derived Indices: Study Protocol for a Prospective, Multicentric, Single, Blind, Randomized, Superiority Study (The LACTEL Study). Front Cardiovasc Med. 2022 Jun 23;9:898406. doi: 10.3389/fcvm.2022.898406. eCollection 2022.
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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?
A Phase 4 study testing collection of biological data, collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data and Standard treatment in people with Hyperlactatemia and Actue Circulatory Failure, run by Centre Hospitalier Universitaire Dijon 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 4 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 29 Jan 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary endpoint is the number of patients with a lactate clearance of more than 10% (change of more than 10% between baseline and the level measured at 2 hours after management) at H2. (time frame: 2 hours after inclusion). 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 NCT05032521, which also lists 2 linked publications.
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 29 Jan 2026.