Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C
- Conditions
- Septic Shock
- Interventions
- Registration Number
- NCT06749756
- Lead Sponsor
- Fan Zeng
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 296
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group 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. Control group 1 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. Control group 2 vitamin C On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days. Control group 3 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.
- Primary Outcome Measures
Name Time Method Improvement of microcirculation 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 Outcome Measures
Name Time Method 28-day mortality 28 days 28-day mortality
Capillary refill time 4 days Capillary refill time during trial medication
Changes in SOFA score 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.
Changes in APACHEII score 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.
Daily change of veno-arterial carbon dioxide differential pressure (GAP) 4 days Daily change of veno-arterial carbon dioxide differential pressure (GAP)
Daily change of central venous oxygen saturation (Scv02) 4 days Daily change of central venous oxygen saturation (Scv02)
Number of days on ventilator 28 days The number of days the patient was ventilator-ventilated within 28 days
The duration of the patient's use of pressor drugs 4 days Duration of pressor drug use during the patient's trial medication
ICU stay 28 days Patient's 28-day ICU stay
Trial Locations
- Locations (1)
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China