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

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Completed
CT.gov ID
NCT03292120
Collaborator
(none)
124
1
1
35
3.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: measure of the SOFA score
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
124 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Venous to Arterial Carbon Dioxide Difference (P₍ᵥ-ₐ₎CO₂): Predictor of Septic Patient Prognosis Depending on the ScvO₂
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: patients with septic shock

Other: measure of the SOFA score
The Sequential Organ Failure Assessment (SOFA) Score predicts ICU mortality based on lab results and clinical data.

Outcome Measures

Primary Outcome Measures

  1. measure of the SOFA score [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • Patient no longer in the initial phase of septic shock

  • Absence of semi-invasive cardiac monitoring with thermodilution

  • Vulnerable people

  • Absence of informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assisitance Publique Hopitaux de Marseille Marseille France 13354

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: jean olivier ARNAUD, Assistance Publique Hopitaux De Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT03292120
Other Study ID Numbers:
  • 2016-07
  • 2016-A00586-45
First Posted:
Sep 25, 2017
Last Update Posted:
May 8, 2019
Last Verified:
May 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 8, 2019