An interventional study of vitamin B6+ Vitamin B12 +vitamin C and vitamin B6+ Vitamin B12 in Septic Shock, sponsored by Fan Zeng. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Fan Zeng · Not applicable, Interventional, and Treatment
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
890 studies on the registry are indexed under Shock, Septic; 210 are open to participants now.
This study's planned enrollment of 296 is above the median of 78 across 547 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →This is the only study on the registry with Fan Zeng as lead sponsor.
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5. Obtain the informed consent of the subject or his family
Exclusion Criteria:
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, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days.
Drug: vitamin B6+ Vitamin B12
On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.
Drug: vitamin C
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
Drug pages: Vitamin B 6 · Pyridoxine · Vitamin B 12 · Ascorbic Acid
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 pages: Vitamin B 6 · Pyridoxine · Vitamin B 12
In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days.
On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.
The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days.
Improvement of microcirculation
Sublingual microcirculation index (including perfusion vessel density (PVD) and total vessel density (TVD)) was measured after initiation of administration.
Time frame: At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.
Improvement of microcirculation
The radial artery resistance index of snus pit was measured after the start of administration.
Time frame: At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.
The duration of the patient's use of pressor drugs
Duration of pressor drug use during the patient's trial medication
Time frame: 4 days
Number of days on ventilator
The number of days the patient was ventilator-ventilated within 28 days
Time frame: 28 days
ICU stay
Patient's 28-day ICU stay
Time frame: 28 days
28-day mortality
28-day mortality
Time frame: 28 days
Capillary refill time
Capillary refill time during trial medication
Time frame: 4 days
Changes in SOFA score
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.
Time frame: 7 days
Changes in APACHEII score
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.
Time frame: 7 days
Daily change of veno-arterial carbon dioxide differential pressure (GAP)
Daily change of veno-arterial carbon dioxide differential pressure (GAP)
Time frame: 4 days
Daily change of central venous oxygen saturation (Scv02)
Daily change of central venous oxygen saturation (Scv02)
Time frame: 4 days
Plan to share: No
Start is estimated for Feb 2025; primary completion for Feb 2026, 12 months later.
Of 144 non-industry interventional studies with no phase under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 12 months is below that.
Counting every sponsor, half of 150 studies reached it within 26 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Vitamin B 6 · Pyridoxine · Vitamin B 12 · Ascorbic Acid