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

NCT04538339 | Completed

• 2 other identifiers: CHRO-2020-112020-A01333-36
• Study Type: observational
• Target: 398
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Circulatory Failure

Keywords

Lactate; arterial blood gas; central venous blood; gazometer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  15 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (10)

CHU d'ANGERS

Angers, France

Location

CHU de DIJON

Dijon, France

Location

Chu de Garches

Garches, France

Location

Chu Limoges

Limoges, France

Location

Hopital de La Timone

Marseille, France

Location

CHU de NANTES

Nantes, 44093, France

Location

Chr D'Orleans

Orléans, France

Location

CHRU de POITIERS

Poitiers, 86021, France

Location

CHU de STRASBOURG

Strasbourg, 67000, France

Location

Ch de Versailles

Versailles, France

Location

Related 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.

  PMID: 27543529 BACKGROUND

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Toufik Kamel, MD

  CHR Orléans, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 4, 2020
• Study Start: September 10, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

FR (10)