Evaluating Prognostic Contribution of Lactate on Recovery of Spontaneous Cardiac Activity After Cardiac Arrest (PROLAC)

A Pilot Study Evaluating the PROgnostic Contribution of Venous Lactate for the Recovery of Spontaneous Cardiac Activity, Following an Extra-hospital Cardiac Arrest "PROLAC Study"

Incidence of non-hospital cardio-respiratory arrest (ACR) in France is around 40 000 cases per year, with mortality remaining very high, with 75% of patients dying before arrival in hospital. The investigators know some validated predictive factors for recovery of spontaneous cardiac activity (RACS) such as age, no flow (time between ACR and onset of CPR), type of initial electrical activity (FV, TVSP), or the value of CO2 expired.

However, the use of these prognostic criteria in the conduct of CPR maneuvering is in practice limited. Lactate is now a well-known prognostic biological marker used in many pathological conditions such as shock states or the severe traumatized patient. Some data have also demonstrated the prognostic value of lactate on morbidity and mortality after ACR after resumption of spontaneous cardiac activity.

The hypothesis of our study is that the evaluation of the initial lactate in the early cardiopulmonary resuscitation could be a prognostic factor of RACS.

Study Overview

• Status: Completed
• Conditions: Cardio-respiratory Arrest, Prolactin
• Intervention / Treatment: Biological: venous lactate

Detailed Description

Incidence of non-hospital cardio-respiratory arrest (ACR) in France is around 40 000 cases per year, with mortality remaining very high, with 75% of patients dying before arrival in hospital. This disease is associated with a high morbidity since today the investigator find less than 5% survival at 1 year with a favorable neurological outcome.

The recommendations of ILCOR 2015 underline in this case the importance of implementing therapeutic measures in the extra-hospital step. Indeed, the survival of ACR patients will depend mainly on the alert delay at the UAS center, the immediate implementation of cardiopulmonary resuscitation (CPR) maneuvers and the early delivery of external electric shock.

The investigators know some validated predictive factors for recovery of spontaneous cardiac activity (RACS) such as age, no flow (time between ACR and onset of CPR), type of initial electrical activity (FV, TVSP), or the value of CO2 expired.

However, the use of these prognostic criteria in the conduct of CPR maneuvering is in practice limited.

Today, none of these prognostic factors allow us to adapt the cardiopulmonary resuscitation maneuvers to the different clinical situations, and it is recognized that a CPR must be carried out for 30 minutes in all cases.

On the basis of these data, it seemed important to investigate other predictive factors for RACS, which would remain simple to implement, and allow case-by-case customization the cardiopulmonary resuscitation.

Lactate is now a well-known prognostic biological marker used in many pathological conditions such as shock states or the severe traumatized patient. Some data have also demonstrated the prognostic value of lactate on morbidity and mortality after ACR after resumption of spontaneous cardiac activity. Unfortunately, all of these studies were carried out intra-hospital. To date, no prospective study has demonstrated the prognostic value of a lactate assay as soon as the pre-hospital medical team arrives and during pre-hospital cardiopulmonary resuscitation.

An experimental study published in the American Journal of Emergency Medicine in 1985, however, suggests that early evaluation of lactate in the course of cardiac arrest may be a valuable prognostic factor. Indeed, in this study on canine cardiac arrest experimental model, Donna et al found that the lactate concentration would reliably predict the no-flow describing an linear increase of lactate as a function of the no-flow duration. If these results can be extrapolated to humans, lactate measurement from the arrival of the pre-hospital medical team could provide an estimate of the no-flow period and therefore a reliable and easily reproducible predictive factor for RACS .

In addition, improvements in biomedical equipment allow us to perform lactate assays directly at the patient's bedside, with reliable results in just 13 seconds.

The hypothesis of our study is that the evaluation of the initial lactate in the early cardiopulmonary resuscitation could be a prognostic factor of RACS.

For this purpose, the investigators propose to carry out a prospective, open, multicenter intervention study in different SMURs in the PACA region, in France.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Provences Alpes Cote d'Azur
    • Nice, Provences Alpes Cote d'Azur, France, 06000
      • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male >18 years of age
• Women over 50 years of age (ie, with amenorrhea> 1 year).
• Victim of non-traumatic cardiopulmonary arrest.
• Medical decision to start or continue cardiopulmonary resuscitation.
• Consent of family or person of trust if present (and patient as soon as possible).
• patient affiliated to the social security

Exclusion Criteria:

• Refusal of family or trusted person to participate in the study
• Pre-paramedical management with use of adrenaline and protection of the airways
• Use of the intraosseous line from the outset or after failure of the peripheral venous pathway by the medical team outside hospital
• Minor Patient
• vulnerable patient under legal protection (guardianship or curators)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cardio-respiratory arrest	Biological: venous lactate; value of venous lactate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
venous lactate	The main evaluation criteria will be the value of the venous lactate that was measured during insertion of the peripheral venous line at the arrival of the medical team (= T0) in patients in cardiac arrest	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial value of capillary lactate	to compare with the initial venous lactate value measured at the peripheral venous laying	at baseline
The no-flow	This data will be obtained by interrogating the witnesses present during the cardiac arrest.	at baseline
The kinetics of capillary lactate	to evaluate by the variability of capillary lactate levels	at time = 10 minutes
The kinetics of capillary lactate	to evaluate by the variability of capillary lactate levels	at time = 20 minutes
The kinetics of capillary lactate	to evaluate by the variability of capillary lactate levels	at time = 30 minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Publications and helpful links

General Publications

• Contenti J, Occelli C, Lemachatti A, Hamard F, Giolito D, Levraut J. Is the lactate value predictive of the return of spontaneous circulation during CPR in nontraumatic OHCA? Am J Emerg Med. 2024 May;79:75-78. doi: 10.1016/j.ajem.2024.02.021. Epub 2024 Feb 19.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2017
• Primary Completion (Actual): August 10, 2020
• Study Completion (Actual): August 10, 2020

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest
• Other Study ID Numbers: 16-AOI-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No