Septic ShockMYTHICCSNCT04778605
Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients
An observational study of Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2021to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Intensive care department- Hôpital saint Antoine
Paris, 75012
Hafid AIT-OUFELLA, Professor, 0149282315, hafid.aitoufella@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Septic Shock
- Keywords
- Endothelial dysfunction, Vitamin C, Septic shock, Microcirculatory effects, Hemodynamic effects
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with septic shock stabilized between H6 and H24 of treatment under noradrenaline. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start26 Jan 2021
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafid AIT-OUFELLA, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778605
- Sponsor's protocol ID
- APHP200301
- Acronym
- MYTHICCS
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35062987
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT04778605
- Acronym / sponsor ID
- MYTHICCS / APHP200301
- Conditions
- Septic Shock
- Keywords
- Endothelial dysfunction, Vitamin C, Septic shock, Microcirculatory effects, Hemodynamic effects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with septic shock stabilized between H6 and H24 of treatment under noradrenaline. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age > 18 years
- Septic shock patient, reanimated and stabilized defined as:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the change in microcirculatory vascular reactivity before and after a 30-minute intravenous infusion of 40 mg / kg vitamin C.
Time frame: 30 minutes
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.
1 secondary outcome
To study the hemodynamic effects of vitamin C on cardiac output, hemodynamic parameters: HR, BP, clinical perfusion parameters: marbling score, cutaneous re-coloring time.
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 35062987Lavillegrand 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.
- Individual participant dataSharing planned: Undecided
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hafid AIT-OUFELLA, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hafid AIT-OUFELLA, Professor (0149282315, hafid.aitoufella@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the change in microcirculatory vascular reactivity before and after a 30-minute intravenous infusion of 40 mg / kg vitamin C. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04778605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.