CClinicalTrials.gg
Sign In
CompletedNCT03292120Updated May 8, 2026

Venous to Arterial Carbon Dioxide Difference (P₍ᵥ-ₐ₎CO₂): Predictor of Septic Patient Prognosis Depending on the ScvO₂

An interventional study of measure of the SOFA score in Septic Shock, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

the investigators will include 120 patients with a diagnosis of septic shock in accordance with the definition given by the 2001 expert consensus. Two groups of patients are likely to participate in this study: Patient hospitalized in intensive care for a septic shock = Primary patient + patient who develops, the waning of his hospitalization in intensive care for another reason, a septic shock = Secondary patient. Haemodynamic monitoring by transpulmonary thermodilution allow a patient's close monitoring during the initial phase supported. The clinical and biological data, demographic and the severity scores are collected for each patient during the first three days of stay. To predict the unfavorable evolution of the patients, a measure of the SOFA score at the input (J0) and third day (J2) is performed. the investigators analyzed mortality at day 28 in patients with increased P₍ᵥ-ₐ₎CO₂ and those with increasing of organ failure. This research will be conducted according to good clinical practice. An information will be distributed to patients.

02

Conditions studied

  • Septic Shock

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient with a diagnosis of septic shock
  • Initial lactate in patients should be≥ 2 mmol / L.
  • The presence of circulatory insufficiency defined by a systolic blood pressure ≤ 90 mmHg (or a drop in blood pressure≥ 50 mmHg in hypertensive patients)
  • One or more of the following: oliguria defined as diuresis≤ 0,5 mL/ kg / h for at least two hours; the presence of signs of cerebral hypoperfusion; the highlighting of mottling
  • The presence of a femoral arterial catheter and a central venous line in the superior vena cava position
  • Hemodynamic monitoring with semi-invasive monitoring of cardiac output with thermodilution

Exclusion criteria

Exclusion Criteria:

  • Patient no longer in the initial phase of septic shock
  • Absence of semi-invasive cardiac monitoring with thermodilution
  • Vulnerable people
  • Absence of informed consent
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
124 participants (actual)

Study arms

  • Experimental
    patients with septic shock

    Other: measure of the SOFA score

Interventions

  • Othermeasure of the SOFA score

    The Sequential Organ Failure Assessment (SOFA) Score predicts ICU mortality based on lab results and clinical data.

05

What researchers measure

Primary outcomes

  1. measure of the SOFA score

    Time frame: 28 days

06

Study locations

1 site
  • Assisitance Publique Hopitaux de Marseille
    Marseille, 13354, France
07

References and documents

Publications

  • Ronfle R, Lefebvre L, Duclos G, Rambaud R, Baumstarck K, Boucekine M, Daviet F, Baldesi O, Papazian L, Leone M. Venous-to-Arterial Carbon Dioxide Partial Pressure Difference: Predictor of Septic Patient Prognosis Depending on Central Venous Oxygen Saturation. Shock. 2020 Jun;53(6):710-716. doi: 10.1097/SHK.0000000000001442. PubMed 31490355 ↗
08

Registry details

Key details

Study ID
NCT03292120
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Jun 2016
Primary completion
Nov 2018
Completion
May 2019
Last update
May 8, 2026

Study contacts

jean olivier ARNAUD
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Shock, Septic→

Other studies from this sponsor

Assistance Publique Hopitaux De Marseille

Start the discussion