Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C

Fan Zeng

Status: Enrolling

Conditions: Septic Shock

Treatments: Drug: 0.9%Nacl; Drug: vitamin B6+ Vitamin B12; Drug: vitamin C; Drug: vitamin B6+ Vitamin B12 +vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT06749756

No. 742-1in2024ofLunShen(Yan）

Details and patient eligibility

About

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

Enrollment: 296 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

4. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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296 participants in 4 patient groups

Experimental group

Experimental group

Description:

In addition to the basic treatment of sepsis, intravenous injection of vitamin B6 300mg qd Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days.

Treatment:

Drug: vitamin B6+ Vitamin B12 +vitamin C

Control group 1

Active Comparator group

Description:

In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days.

Treatment:

Drug: vitamin B6+ Vitamin B12

Control group 2

Active Comparator group

Description:

On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.

Treatment:

Drug: vitamin C

Control group 3

Active Comparator group

Description:

The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days.

Treatment:

Drug: 0.9%Nacl