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Completed

NCT Number: NCT03292120

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assisitance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

measure of the SOFA score

Other

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

Primary outcomes

  1. measure of the SOFA score

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 25, 2017
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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