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

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

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.

Study Overview

• Status: Completed
• Conditions: Circulatory Failure

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 398

Contacts and Locations

• Study Contact: Name: Thierry Boulain, MD; Phone Number: 33238514444; Email: thierry.boulain@chr-orleans.fr
• Study Contact Backup: Name: Aurélie Despujols; Phone Number: 33238514444; Email: aurelie.despujols@chr-orleans.fr

Study Locations

• France
  • Angers, France
    • CHU d'Angers
  • Dijon, France
    • CHU de Dijon
  • Garches, France
    • Chu de Garches
  • Limoges, France
    • Chu Limoges
  • Marseille, France
    • Hopital de la Timone
  • Nantes, France, 44093
    • CHU de Nantes
  • Orléans, France
    • CHR d'Orléans
  • Poitiers, France, 86021
    • CHRU de POITIERS
  • Strasbourg, France, 67000
    • CHU de Strasbourg
  • Versailles, France
    • CH de Versailles

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Studied patients will be adult patients admitted to intensive car unit and presenting signs of acute circulatory failure. Patients should carry arterial and central venous catheters for their medical needs and not exclusively for the purpose of the study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Bias and agreement interval between predicted and actual arterial values for each variable of interest.	15 minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Toufik Kamel, MD, CHR Orléans, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: August 29, 2020
• First Submitted That Met QC Criteria: August 29, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Lactate; arterial blood gas; central venous blood; gazometer
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: CHRO-2020-11; 2020-A01333-36 (Other Identifier: IDRCB number issued by French Government)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No