Prediction of Arterial Lactate and Blood Gas Values Through the Analysis of Central Venous Blood

NCT ID: NCT04538339

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

398 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-10

Study Completion Date

2023-03-30

Brief Summary

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Predicting arterial lactate and blood gas values with sufficient accuracy by simply analyzing central venous blood would be interesting in intensive care unit patients in whom the insertion of an arterial catheter or arterial punctures could be avoided. This prospective study aims at externally validating published mathematical models built to predict arterial values from central venous blood analysis.

Detailed Description

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Mathematical models for predicting arterial blood gas and arterial lactate have recently be published (PMID 27543529; see the citations section). The aim of the study is to externally validate these models in a multicenter (11 centres in France) cohort of intensive care unit patients suffering from acute circulatory failure. For the peru pose of the study, patients will undergo concomitent central venous/arterial blood sampling from 1 to 4 times during their intensive cafe unit stay. Clinical characteristics of the patients and central venous blood gas and lactate values will be used to predicted arterial values according to previously published formula. Predicted and actual arterial values of each variable of interest (pH, PaCO2, SaO2, lactate) will then be compared.

Conditions

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Circulatory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age\>18 years
* patient admitted in a intensive care unit
* patient already carrying an indwelling arterial catheter and a superior vena cava central catheter
* patient presenting an acute circulatory failure defined by the presence of at least two of the following items: a) Persistent hypotension (systolic arterial blood pressure \< 90 mm Hg or mean arterial pressure \< 65 mm Hg) or need for continuous intravenous vasopressor treatment (at any dose). b) Presence of at least one of the following signs of hypoperfusionfusion :Change in mental status ; Skin mottling ; Oliguria (Urine output \<0.5 ml/kg body weight for at least one hour); Arterial lactate \> 2 mmol/l or peripheral venous lactate \> 3.2 mmol/l; ScvO2 \<70%.
* Routine medical management requires central venous blood sampling for ScvO2 measurement and arterial blood sampling for gazometry.

Exclusion Criteria

* Opposition to participation in the study
* Impossibility to take a concomitant arterial and venous gazometric sample.
* Patient treated with ECMO (extracorporeal membrane,oxygrnation), intermittent dialysis or continuous dialysis during sampling
* Patient hospitalized without consent and/or deprived of liberty by court decision.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toufik Kamel, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Orléans, France

Locations

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CHU d'ANGERS

Angers, , France

Site Status

CHU de DIJON

Dijon, , France

Site Status

Chu de Garches

Garches, , France

Site Status

Chu Limoges

Limoges, , France

Site Status

Hopital de La Timone

Marseille, , France

Site Status

CHU de NANTES

Nantes, , France

Site Status

Chr D'Orleans

Orléans, , France

Site Status

CHRU de POITIERS

Poitiers, , France

Site Status

CHU de STRASBOURG

Strasbourg, , France

Site Status

Ch de Versailles

Versailles, , France

Site Status

Countries

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France

References

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Boulain T, Garot D, Vignon P, Lascarrou JB, Benzekri-Lefevre D, Dequin PF; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Predicting arterial blood gas and lactate from central venous blood analysis in critically ill patients: a multicentre, prospective, diagnostic accuracy study. Br J Anaesth. 2016 Sep;117(3):341-9. doi: 10.1093/bja/aew261.

Reference Type BACKGROUND
PMID: 27543529 (View on PubMed)

Other Identifiers

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2020-A01333-36

Identifier Type: OTHER

Identifier Source: secondary_id

CHRO-2020-11

Identifier Type: -

Identifier Source: org_study_id

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