Clinical trial NCT06749756: Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C
Official title: Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Septic Shock
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Improvement of microcirculation
timeFrame: At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.
measure: Improvement of microcirculation
timeFrame: At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.
Secondary outcomes:
measure: The duration of the patient's use of pressor drugs
timeFrame: 4 days
measure: Number of days on ventilator
timeFrame: 28 days
measure: ICU stay
timeFrame: 28 days
measure: 28-day mortality
timeFrame: 28 days
measure: Capillary refill time
timeFrame: 4 days
measure: Changes in SOFA score
timeFrame: 7 days
measure: Changes in APACHEII score
timeFrame: 7 days
measure: Daily change of veno-arterial carbon dioxide differential pressure (GAP)
timeFrame: 4 days
measure: Daily change of central venous oxygen saturation (Scv02)
timeFrame: 4 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References:
citation: Wald EL, Badke CM, Hintz LK, Spewak M, Sanchez-Pinto LN. Vitamin therapy in sepsis. Pediatr Res. 2022 Jan;91(2):328-336. doi: 10.1038/s41390-021-01673-6. Epub 2021 Jul 31.
citation: Giustina AD, Danielski LG, Novochadlo MM, Goldim MPS, Joaquim L, Metzker KLL, Carli RJ, Denicol T, Cidreira T, Vieira T, Petronilho F. Vitamin B6 reduces oxidative stress in lungs and liver in experimental sepsis. An Acad Bras Cienc. 2019 Dec 2;91(4):e20190434. doi: 10.1590/0001-3765201920190434. eCollection 2019.
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