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NCT Number: NCT06749756

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

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 and < 85 years old
  • Admitted to ICU
  • Diagnosis of patients with SEPSIS 3.0 (diagnostic criteria) 4, SOFA score is 2-13 points
  • Obtain the informed consent of the subject or his family

Exclusion criteria

  • Patients have absolute contraindications such as vitamin allergy
  • Patients with a history of gout
  • Death is expected within 24 hours
  • Pregnant women
  • Use hydroprednisone or other equivalent dose hormones > 200mg/d within 24 hours
  • Without the informed consent of the patient or his/her representative
  • Patients with a history of scleroderma
  • Patients with a history of vasculitis
  • Patients with oral mucosal diseases
  • Patients with severe difficulty in opening their mouth and unable to detect sublingual microcirculation

Treatment and study plan

vitamin B6+ Vitamin B12 +vitamin C

Drug

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.

vitamin B6+ Vitamin B12

Drug

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

Vitamin C

Drug

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

0.9%NaCl

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. Number of days on ventilator

    Time frame: 28 days

    The number of days the patient was ventilator-ventilated within 28 days

  3. ICU stay

    Time frame: 28 days

    Patient's 28-day ICU stay

  4. 28-day mortality

    Time frame: 28 days

    28-day mortality

  5. Capillary refill time

    Time frame: 4 days

    Capillary refill time during trial medication

  6. 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. 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.

  8. Daily change of veno-arterial carbon dioxide differential pressure (GAP)

    Time frame: 4 days

    Daily change of veno-arterial carbon dioxide differential pressure (GAP)

  9. Daily change of central venous oxygen saturation (Scv02)

    Time frame: 4 days

    Daily change of central venous oxygen saturation (Scv02)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fan Zeng

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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