Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients

NCT04778605 | Unknown

• 1 other identifier: APHP200301
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

Endothelial dysfunction; Vitamin C; Septic shock; Microcirculatory effects; Hemodynamic effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To study the hemodynamic effects of vitamin C on cardiac output, hemodynamic parameters: HR, BP, clinical perfusion parameters: marbling score, cutaneous re-coloring time.

  30 minutes

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnant or nursing women,
• Ward or curative patient
• Moribund patient
• Estimated life expectancy less than 1 month

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Intensive care department- Hôpital saint Antoine

Paris, 75012, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 35062987 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Hafid AIT-OUFELLA, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafid AIT-OUFELLA, Professor

CONTACT

0149282315; hafid.aitoufella@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: January 26, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-02

Locations

FR (1)