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

Primary Purpose

Septic Shock

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

measure of the SOFA score

About this trial

This is an interventional prevention trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Assisitance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with septic shock

Arm Description

Outcomes

Primary Outcome Measures

measure of the SOFA score

Secondary Outcome Measures

Full Information

NCT ID

NCT03292120

First Posted

September 20, 2017

Last Updated

May 7, 2019

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT03292120

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

November 2018 (Actual)

Study Completion Date

May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

patients with septic shock

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

measure of the SOFA score

Intervention Description

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

Primary Outcome Measure Information:

Title

measure of the SOFA score

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

jean olivier ARNAUD

Organizational Affiliation

Assistance Publique Hopitaux De Marseille

Official's Role

Study Director

Facility Information:

Facility Name

Assisitance Publique Hopitaux de Marseille

City

Marseille

ZIP/Postal Code

13354

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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