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

Circulatory Failure Clinical Trial

— PREDIGAZ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538339
• Other study ID #: CHRO-2020-11
• Secondary ID: 2020-A01333-36
• Status: Completed
• Start date: September 10, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Circulatory Failure
• Shock

Locations

Country	Name	City	State
France	CHU d'ANGERS	Angers
France	CHU de DIJON	Dijon
France	Chu de Garches	Garches
France	Chu Limoges	Limoges
France	Hopital de La Timone	Marseille
France	CHU de NANTES	Nantes
France	Chr D'Orleans	Orléans
France	CHRU de POITIERS	Poitiers
France	CHU de STRASBOURG	Strasbourg
France	Ch de Versailles	Versailles

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage error rate when predicting arterial values (pH, PaCO2, SaO2 and lactate) from central venous values.	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.	15 minutes
Secondary	Bias and agreement interval between predicted and actual arterial values for each variable of interest.		15 minutes