Septic Shock
Conditions
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
Interventions
DRUGvitamin 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.
DRUGvitamin 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.
DRUGvitamin C
On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.
DRUG0.9%Nacl
The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days.
Sponsors
Fan Zeng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of microcirculation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days on ventilator | 28 days | The number of days the patient was ventilator-ventilated within 28 days |
| ICU stay | 28 days | Patient's 28-day ICU stay |
| 28-day mortality | 28 days | 28-day mortality |
| Capillary refill time | 4 days | Capillary refill time during trial medication |
| The duration of the patient's use of pressor drugs | 4 days | Duration of pressor drug use during the patient's trial medication |
| 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) |
| 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. |
Countries
China
Contacts
Primary Contactfan Zeng
Backup Contactqin Xu
Outcome results
None listed