Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-26

Study Completion Date

2021-07-31

Brief Summary

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Compare the microcirculatory reactivity before and after a 30-minute intravenous infusion of 40 mg/kg vitamin C and evaluate intra-individual variation of hemodynamic parameters between T0 and T1.

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Detailed Description

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This is a transversal study allowing to compare the microcirculatory reactivity before and after a 30-minute intravenous infusion of 40 mg/kg vitamin C.

Design:

• A monocentric, open-label, transversal study

Sample size :

30 patients

Assessement:

Between 6 hours and 24 hours after admission, the patient will be included after collection of the non opposition.

There will be two evaluation times: T0 before the start of vitamin C's perfusion, and T1: 1 hour after the end.

No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of data base.

Conditions

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Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with septic shock stabilized between H6 and H24 of treatment under noradrenaline.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Septic shock patient, reanimated and stabilized defined as:

* Patients with sepsis (suspected infection + 2 SOFA points) according to the latest international and the need to receive norepinephrine to maintain an average blood pressure above 65 mmHg
* Patient supported for at least 6 hours, necessary for diagnostic management and hemodynamic optimization according to international standards and for less than 24 hours to limit confounding factors related to prolonged reanimation (sedation) and the empowerment of organ failures in general and vascular in particular. Hemodynamic stabilization will be defined as no increase in norepinephrine dosages

Exclusion Criteria

* Pregnant or nursing women,
* Participation in another intervention research involving the human person or exclusion period following a previous research involving the human person
* Ward or curative patient
* Moribund patient
* Estimated life expectancy less than 1 month

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No