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

February 4, 2025 updated by: Fan Zeng
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

296

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610031
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
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.
Drug: vitamin B6+ Vitamin B12 +vitamin C
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.
Active Comparator: Control group 1
In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days.
Drug: vitamin B6+ Vitamin B12
In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days.
Active Comparator: Control group 2
On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.
Drug: vitamin C
On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.
Active Comparator: Control group 3
The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days.
Drug: 0.9%Nacl
The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of microcirculation
Time Frame: At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.
Sublingual microcirculation index (including perfusion vessel density (PVD) and total vessel density (TVD)) was measured after initiation of administration.
At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.
Improvement of microcirculation
Time Frame: At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.
The radial artery resistance index of snus pit was measured after the start of administration.
At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 28 days
28-day mortality
28 days
The duration of the patient's use of pressor drugs
Time Frame: 4 days
Duration of pressor drug use during the patient's trial medication
4 days
Number of days on ventilator
Time Frame: 28 days
The number of days the patient was ventilator-ventilated within 28 days
28 days
ICU stay
Time Frame: 28 days
Patient's 28-day ICU stay
28 days
Capillary refill time
Time Frame: 4 days
Capillary refill time during trial medication
4 days
Changes in SOFA score
Time Frame: 7 days
Changes in SOFA scores on day 3 and day 7 compared with baseline values at randomization.The SOFA Score (Sequential Organ Failure Assessment Score) is a scoring system used to assess the severity of organ dysfunction in critically ill patients. It consists of six systems: respiratory, blood, liver, cardiovascular, nervous and kidney, with each system scored according to the degree of dysfunction on a scale of 0 (normal) to 4 (severe impairment or failure). The score of SOFA is closely related to the mortality and prognosis of patients. The higher the score, the higher the mortality.
7 days
Changes in APACHEII score
Time Frame: 7 days
Changes in APACHEII scores on day 3 and day 7 compared with baseline values at randomization.The Apache II score, also known as the Acute Physiological and Chronic Health Assessment (APACHE II), is a scoring system used to assess the severity of a critically ill patient's condition and predict prognosis. The theoretical maximum value is 71 points, and the higher the score, the more severe the disease, the worse the prognosis and the higher the fatality rate.
7 days
Daily change of veno-arterial carbon dioxide differential pressure (GAP)
Time Frame: 4 days
Daily change of veno-arterial carbon dioxide differential pressure (GAP)
4 days
Daily change of central venous oxygen saturation (Scv02)
Time Frame: 4 days
Daily change of central venous oxygen saturation (Scv02)
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fan Zeng

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 10, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

December 7, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. 742-1in2024ofLunShen(Yan）

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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