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

Primary Purpose

Cardio-respiratory Arrest, Prolactin

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
venous lactate
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardio-respiratory Arrest, Prolactin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cardio-respiratory arrest

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Initial value of capillary lactate
to compare with the initial venous lactate value measured at the peripheral venous laying
The no-flow
This data will be obtained by interrogating the witnesses present during the cardiac arrest.
The kinetics of capillary lactate
to evaluate by the variability of capillary lactate levels
The kinetics of capillary lactate
to evaluate by the variability of capillary lactate levels
The kinetics of capillary lactate
to evaluate by the variability of capillary lactate levels

Full Information

First Posted
October 23, 2017
Last Updated
April 11, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT03325452
Brief Title
Evaluating Prognostic Contribution of Lactate on Recovery of Spontaneous Cardiac Activity After Cardiac Arrest
Acronym
PROLAC
Official Title
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"
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
August 10, 2020 (Actual)
Study Completion Date
August 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardio-respiratory Arrest, Prolactin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cardio-respiratory arrest
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
venous lactate
Intervention Description
value of venous lactate
Primary Outcome Measure Information:
Title
venous lactate
Description
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
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
Initial value of capillary lactate
Description
to compare with the initial venous lactate value measured at the peripheral venous laying
Time Frame
at baseline
Title
The no-flow
Description
This data will be obtained by interrogating the witnesses present during the cardiac arrest.
Time Frame
at baseline
Title
The kinetics of capillary lactate
Description
to evaluate by the variability of capillary lactate levels
Time Frame
at time = 10 minutes
Title
The kinetics of capillary lactate
Description
to evaluate by the variability of capillary lactate levels
Time Frame
at time = 20 minutes
Title
The kinetics of capillary lactate
Description
to evaluate by the variability of capillary lactate levels
Time Frame
at time = 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
CHU de Nice
City
Nice
State/Province
Provences Alpes Cote d'Azur
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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

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