Clinical trial NCT04778605: Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients
Official title: Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Keywords: Endothelial dysfunction
Vitamin C
Septic shock
Microcirculatory effects
Hemodynamic effects
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: During septic shock, there are microcirculatory abnormalities, partly related to oxidative stress, which contribute to the pathophysiology of organ failures. We systematically supplement septic shock patients admitted in intensive care with vitamin C (ascorbic acid) because of the frequency of vitamin deficiencies in this population. Vitamin C having anti-oxidant properties, we hypothesized that Vitamin C's infusion could modulate microcirculatory endothelial reactivity in septic shock patients. This trial will allow us to include patients in stabilized septic shock between H6 and H24 of patient's care under norepinephrine.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the change in microcirculatory vascular reactivity before and after a 30-minute intravenous infusion of 40 mg / kg vitamin C.
timeFrame: 30 minutes
Secondary outcomes:
measure: To study the hemodynamic effects of vitamin C on cardiac output, hemodynamic parameters: HR, BP, clinical perfusion parameters: marbling score, cutaneous re-coloring time.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Paris
country: France
facility: Intensive care department- Hôpital saint Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hafid AIT-OUFELLA, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavillegrand JR, Raia L, Urbina T, Hariri G, Gabarre P, Bonny V, Bige N, Baudel JL, Bruneel A, Dupre T, Guidet B, Maury E, Ait-Oufella H. Vitamin C improves microvascular reactivity and peripheral tissue perfusion in septic shock patients. Crit Care. 2022 Jan 21;26(1):25. doi: 10.1186/s13054-022-03891-8.