Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients

Septic Shock Clinical Trial

— MYTHICCS  

Official title:

Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04778605
• Other study ID #: APHP200301
• Status: Recruiting
• Start date: January 26, 2021
• Est. completion date: July 2021

Study information

• Verified date: February 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Hafid AIT-OUFELLA, Professor
• Phone: 0149282315
• Email: hafid.aitoufella[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
France	Intensive care department- Hôpital saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the change in microcirculatory vascular reactivity before and after a 30-minute intravenous infusion of 40 mg / kg vitamin C.	Change (%) in microcirculatory vascular reactivity. T0 being measured just before the start of the vitamin C infusion. T1 being measured immediately after the 30-minute vitamin C infusion. The microcirculatory vascular reactivity will be evaluated using a cutaneous doppler laser coupled to an iontophoresis system. The doppler laser measures the skin perfusion on a sample of skin. A low intensity electric field is delivered for 12 seconds (3 times in a row at 1 minute interval) and allows local skin diffusion of an ionized solution of acetylcholine placed on the skin in a micro-sponge. It has been shown that this technique is very precise and that it is a very good reflection of endothelial function by measuring 3 parameters, the microcirculatory basal flow, the peak in response to acetylcholine and a more integrative index, the area under the curve with a standardized 10-minute recording. This local technique does not induce any side effects, it is very well tolerated.	30 minutes
Secondary	To study the hemodynamic effects of vitamin C on cardiac output, hemodynamic parameters: HR, BP, clinical perfusion parameters: marbling score, cutaneous re-coloring time.	Variation (%) in cardiac output between T0 and T1 (echocardiography) ((T1-T0) / T0x100).; Variation (%) of hemodynamic parameters between T0 and T1 ((T1-T0) / T0x100): Heart Rate, Blood Pressure, Cardiac output; Variation (%) of clinical perfusion parameters between T0 and T1 between T0 and T1: mottling score, skin recoloration time.; All these parameters are routinely measured as part of the management of septic shock.	30 minutes