Improving blood flow in sepsis patients using vitamins
Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C
This study is testing if giving a mix of vitamins B6, B12, and C to patients with sepsis in the ICU can improve their blood flow and help them recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 296 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Sichuan Cancer Hospital and Research Institute Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06749756 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of vitamin B6, vitamin B12, and vitamin C on microcirculation and organ dysfunction in patients diagnosed with sepsis. A total of 296 patients will be randomized into different groups, with one group receiving a combination of all three vitamins alongside standard sepsis treatment, while control groups will receive varying combinations of the vitamins. The aim is to determine if this vitamin regimen can enhance survival rates and improve clinical outcomes in septic patients. The study focuses on patients in the ICU with a specific diagnosis of sepsis and a defined severity score.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 who are admitted to the ICU with a diagnosis of sepsis.
Not a fit: Patients with vitamin allergies, severe comorbidities, or those expected to die within 24 hours will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and recovery in patients suffering from sepsis.
How similar studies have performed: While the use of vitamins in sepsis treatment is a novel approach, previous studies have shown mixed results regarding the efficacy of antioxidants in improving outcomes in critically ill patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chengdu, Sichuan
- Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: fan Zeng
- Email: zengfan1985@126.com
- Phone: 17744339835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.