NCT06749756 Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C
| NCT ID | NCT06749756 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fan Zeng |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 296 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 296 participants in total. It began in 2025-02-10 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sepsis is a kind of disease with high morbidity and mortality in ICU. At present, there is no specific treatment, and its pathogenesis is mainly excessive oxidative stress. Anti-inflammatory, antioxidant and immune-regulating drugs may produce better therapeutic effects, while vitamin B6, vitamin B12 and vitamin C have anti-inflammatory, antioxidant and immune-regulating effects. The purpose of this study was to investigate whether vitamin B6, vitamin B12 combined with vitamin C can improve the microcirculation and organ dysfunction in patients with sepsis, and improve the survival rate of patients with sepsis. The study included 296 patients who met the inclusion criteria. After randomization, the experimental group was given intravenous vitamin B6 300mg qd in addition to the basic treatment of sepsis Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days. Control group 1 was given vitamin B6 300mg qd and vitamin B12 0.5mg q6h intravenously for 4 days. Control group 2 was injected with vitamin C 50mg/kg q6h intravenously for 4 days. Control group 3: The same dose of placebo (0.9% sodium chloride solution) was administered for 4 days. After medication, sublingual microcirculation image and radial artery resistance index of snus pit were detected and recorded according to the time required by the study protocol. The duration of use of pressor drugs, ventilator days, ICU stay, 28-day mortality, capillary refill time, changes in SOFA score and APACHEII score on day 3 and day 7 compared with baseline values at randomization, daily veno-arterial carbon dioxide differential pressure (GAP) and central venous oxygen saturation were recorded. After the end of the experiment, statistical analysis of the data was carried out to further explore the test results
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 and \< 85 years old 2. Admitted to ICU 3. Diagnosis of patients with SEPSIS 3.0 (diagnostic criteria) 4, SOFA score is 2-13 points 5\. Obtain the informed consent of the subject or his family Exclusion Criteria: 1. Patients have absolute contraindications such as vitamin allergy 2. Patients with a history of gout 3. Death is expected within 24 hours 4. Pregnant women 5. Use hydroprednisone or other equivalent dose hormones \> 200mg/d within 24 hours 6. Without the informed consent of the patient or his/her representative 7. Patients with a history of scleroderma 8. Patients with a history of vasculitis 9. Patients with oral mucosal diseases 10. Patients with severe difficulty in opening their mouth and unable to detect sublingual microcirculation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06749756 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06749756 currently recruiting?
Yes, NCT06749756 is actively recruiting participants. Contact the research team at zengfan1985@126.com for enrollment information.
Where is the NCT06749756 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06749756 clinical trial?
NCT06749756 is sponsored by Fan Zeng. The trial plans to enroll 296 participants.