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

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.

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Key information

Conditions

Circulatory Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'ANGERS, Angers, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Percentage error rate when predicting arterial values (pH, PaCO2, SaO2 and lactate) from central venous values.

Time frame: 15 minutes

For each variable of interest (pH, PaCO2, SaO2 and lactate), the percentage of predicted values outside the agreement interval obtained in a previously published study (i.e., -0.078 to +0.084 for arterial pH; -1.32 to +1.36 kPa for PaCO2; -5.15 to +4.47% for SaO2; 1.07 to +1.05 mmol/l for arterial lactate) will be calculated.

Secondary outcomes

Bias and agreement interval between predicted and actual arterial values for each variable of interest.

Time frame: 15 minutes

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Prediction of Arterial Lactate and Blood Gas Values Through the Analysis of Central Venous Blood. A Human, Prospective, Multicenter Validation Study.

Acronym: PREDIGAZ

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Sep 4, 2020
Registry last updated: Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed