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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with septic shock stabilized between H6 and H24 of treatment under noradrenaline. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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).
All these parameters are routinely measured as part of the management of septic shock. |
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Inclusion Criteria:
Age > 18 years
Septic shock patient, reanimated and stabilized defined as:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hafid AIT-OUFELLA, Professor | Contact | 0149282315 | hafid.aitoufella@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Hafid AIT-OUFELLA, Professor | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive care department- Hôpital saint Antoine | Recruiting | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35062987 | Derived | 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. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| 30 minutes |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |