NCT05220696

Brief Summary

The optimal management of shock states requires a precise evaluation of several parameters, clinical, biological, hemodynamic, and echocardiographic. Among these, parameters that measure O2 and CO2 consumption are of a great interest, especially PCO2 arteriovenous gradient (PCO2 gap) and O2 arteriovenous difference \[D(a-v) O2\]. The PCO2 gap best correlates with cardiac output while the PCO2gap/D(a-v)O2 ratio would be earlier and more specific than blood lactate assay in assessing tissue hypoperfusion secondary to shock. The PCO2 gap and the PCO2gap/D (a-v) O2 ratio have been evaluated from gas measurements of venous blood collected from the pulmonary artery and from the superior vena cava area. However, in some patients the placement of a catheter in the superior vena cava is difficult or even impossible due to thrombosis, vascular occlusions and other reasons… In these cases, the inferior vena cava is used for drugs infusion, nutrition and possibly samples. Gasometric samples in lower cellar territory have not yet been validated and may not be correlated with measurements in upper cellar territory. It is therefore useful for current practice to validate samples in lower cellar territory and demonstrate their correlation with measurements made in upper cellar territory. During an observation period, in patients with catheters in the superior and inferior vena cava for therapeutic indications (renal replacement therapy,...), the investigators systematically took gas measurements at the femoral and jugular sites. the investigators used these data to assess the correlation of PCO2 gap measurements and carbon dioxide-derived indices according to the harvest site : jugular and femoral venous.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

January 17, 2022

Last Update Submit

February 1, 2022

Conditions

Keywords

Adult > 18 YOVenous catheter in femoral and jugular sitesArterial cathetercentral venous to arterial carbon dioxide differencecentral venous to arterial carbon dioxide difference to arterial to venous oxygen differencecentral venous oxygen saturation

Outcome Measures

Primary Outcomes (1)

  • The correlation of the measurement of indices derived from carbon dioxide (CO2)

    To assess the correlation of the measurement of indices derived from carbon dioxide (CO2) according to the femoral or jugular harvest site in the critically ill patient. Measurements included venous pCO2 and pO2, and central venous saturation ; arterial pO2 and pCO2. From these measurements, carbon dioxides and oxygen variables were calculated as follows : PCO2gap= Pv-aCO2= PvCO2 -PaCO2, where PaCO2 and PvCO2 represent their arterial and venous partial pressures respectively D(a-v)O2= CaO2- CvO2= \[(hg x SaO2 x 1.34) + (Pa02 x O.OO3)\]- \[(hg x SvO2 x 1.34) + (Pv02 x O.OO3)\], where CaO2 and CvO2 are the arterial and venous 02 content, PaO2 and PvO2 represent their arterial and venous partial pressures respectively. Venous measurements are realized in both venous jugular and femoral sites.

    day 1

Secondary Outcomes (1)

  • To assess the correlation of the measurement of venous O2 saturation

    day 1

Study Arms (1)

Critically ill patients with shock

Critically ill patients with shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients

You may qualify if:

  • \- All consecutive critically ill patients who had an arterial catheter and a venous catheter in the superior and inferior vena cava were included.

You may not qualify if:

  • An age under 18
  • Pregnancy
  • Legally protected adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

NC

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kada KLOUCHE, MD PhD

    UH Montpellier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 17, 2022

First Posted

February 2, 2022

Study Start

July 1, 2020

Primary Completion

October 1, 2020

Study Completion

October 20, 2020

Last Updated

February 2, 2022

Record last verified: 2022-01

Locations