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

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ClinicalTrials.gov Identifier: NCT03292120
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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
Septic Shock Other: measure of the SOFA score Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
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 : June 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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.




Primary Outcome Measures :
  1. measure of the SOFA score [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292120


Locations
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France
Assisitance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: jean olivier ARNAUD Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03292120     History of Changes
Other Study ID Numbers: 2016-07
2016-A00586-45 ( Other Identifier: n°IDRCB )
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock