Septic Shock
Conditions
Keywords
septic shock, glucocorticoid, vitamin C, microcirculation, Vitamin B1
Brief summary
This study aimed to investigate the effect of Glucocorticoid combined with vitamin C and vitamin B1 versus hydrocortisone alone on microcirculation in septic shock patients.
Detailed description
This prospective, double-blind, randomized, controlled trial enrolled septic shock patients admitted to the intensive care unite of a tertiary teaching hospital. We randomly assigned the enrolled patients to the treatment group (hydrocortisone combined with vitamin C and vitamin B1 added to standard care) and the control group (hydrocortisone alone added to standard care) in a 1:1 ratio. The primary outcome was perfusion vascular density (PVD) at 24 hours after treatment. We used the sublingual microcirculation imaging system to monitor PVD. We further validated the primary outcome by observing differences in renal perfusion monitored by renal contrast-enhanced ultrasound (CEUS) between the treatment group and the control group.
Interventions
DRUGGlucocorticoid combination therapy
Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.
DRUGGlucocorticoid
The glucocorticoid group was defined as the use of hydrocortisone alone.
Sponsors
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Septic shock 2. A dose of norepinephrine (\>15ug/min) 3. Age ≥18 and ≤80 years old 4. Signing Informed Consent
Exclusion criteria
1. Meet the inclusion criteria for more than 12 hours 2. Clinician judges that corticosteroid therapy should not be used 3. Pregnant 4. Uncontrolled malignancy 5. Glucocorticoid therapy was used within seven days before admission. 6. Expected death within 24 hours 7. The sublingual microcirculation cannot be measured
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perfused vessel density (PVD) | 24 hours after treatment | Determinant of capillary diffusive capacity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of perfusion vessels | 24 hours after treatment | sublingual microcirculation parameter |
| total vascular density | 24 hours after treatment | sublingual microcirculation parameter |
| microvascular flow index | 24 hours after treatment | sublingual microcirculation parameter |
| renal contrast-enhanced ultrasound parameters | 24 hours after treatment | renal perfusion |
| lactate | 24 hours after treatment | Tissue perfusion parameter |
Countries
China
Outcome results
None listed