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CompletedNCT05032521LACTELUpdated Jan 29, 2026

Treatment of Hyperlactatemia in Acute Circulatory Failure Based on Analysis of CO2: a Prospective Randomized Superiority Study (The LACTEL Study)

A Phase 4 interventional study of collection of biological data and collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data in Hyperlactatemia and Actue Circulatory Failure, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Centre Hospitalier Universitaire Dijon · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hyperlactatemia
  • Actue Circulatory Failure

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03

In context

Hyperlactatemia

50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.

This study's enrollment of 180 is above the median of 38 across 32 interventional studies indexed under Hyperlactatemia.

Browse Hyperlactatemia studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Oral, free and 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • Active comparator
    standard practice

    Biological: collection of biological data · Other: collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data · Procedure: Standard treatment

  • Experimental
    algorithm

    Biological: collection of biological data · Other: collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data · Procedure: stratified treatment according to algorithm

Interventions

  • Biologicalcollection of biological data

    collection of biological data

  • Othercollection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data

    These data are usually measured continuously (monitoring of the resuscitation patient) and recorded on recorded on the resuscitation software.

  • ProcedureStandard treatment

    usual management based on the use of drugs according to international recommendations

  • Procedurestratified treatment according to algorithm

    management based on arteriovenous CO2 gradient Stratification of drug use

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Chu Dijon Bourgogne
    Dijon, 21000, France
08

References and documents

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 39615831 ↗
  • Caruso 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2021 to primary completion in Nov 2023, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2021
First posted
Sep 2, 2021
StartActual
Nov 2, 2021
Primary completionActual
Nov 30, 2023
CompletionActual
Nov 30, 2023
Last update
Jan 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05032521
Responsible party
Sponsor
First posted
Sep 2, 2021
Start date
Nov 2, 2021
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023
Last update
Jan 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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