Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients (MYTHICCS)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Septic Shock

Study type: Observational

Funder types: Other

Identifiers

NCT04778605

APHP200301

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

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