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

NCT03292120 | Completed

• 2 other identifiers: 2016-072016-A00586-45
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• measure of the SOFA score

  28 days

Study Arms (1)

patients with septic shock

EXPERIMENTAL

Other: measure of the SOFA score

Interventions

measure of the SOFA score OTHER

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

patients with septic shock

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assisitance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• 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.

  PMID: 31490355 RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• jean olivier ARNAUD

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: June 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: May 1, 2019
• Last Updated: May 8, 2026

Record last verified: 2019-05

Locations

FR (1)