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

NCT05032521 | Completed Phase 4

• 1 other identifier: GUINOT 2021-3
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperlactatemia; Actue Circulatory Failure

Outcome Measures

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.

  2 hours after inclusion

Study Arms (2)

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

Interventions

collection of biological data BIOLOGICAL

collection of biological data

algorithm; standard practice

collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data OTHER

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

algorithm; standard practice

Standard treatment PROCEDURE

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

standard practice

stratified treatment according to algorithm PROCEDURE

management based on arteriovenous CO2 gradient Stratification of drug use

algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (2)

• 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.

  PMID: 39615831 RESULT

• 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.

  PMID: 35811716 DERIVED

MeSH Terms

Conditions

Hyperlactatemia

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: November 2, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

FR (1)