Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06749756

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

Led by Fan Zeng · Updated on 2025-02-05

296

Participants Needed

1

Research Sites

54 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to less than 85 years old
  • Admitted to ICU
  • Diagnosed with sepsis according to SEPSIS 3.0 criteria
  • SOFA score between 2 and 13 points
  • Informed consent obtained from the participant or family
Not Eligible

You will not qualify if you...

  • Allergy to vitamins
  • History of gout
  • Expected death within 24 hours
  • Pregnant women
  • Use of hydroprednisone or equivalent hormones over 200mg/day within 24 hours
  • No informed consent from patient or representative
  • History of scleroderma
  • History of vasculitis
  • Oral mucosal diseases
  • Severe difficulty opening mouth preventing sublingual microcirculation detection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China, 610031

Actively Recruiting

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Research Team

F

fan Zeng

CONTACT

Q

qin Xu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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