Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 on Microcirculation in Severe Septic Shock

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 Versus Hydrocortisone Alone on Microcirculation in Severe Septic Shock

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Glucocorticoid combination therapy
* Drug: Glucocorticoid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Septic shock A dose of norepinephrine (>15ug/min) Age ≥18 and ≤80 years old Signing Informed Consent Exclusion Criteria: Meet the inclusion criteria for more than 12 hours Clinician judges that corticosteroid therapy should not be used Pregnant Uncontrolled malignancy Glucocorticoid therapy was used within seven days before admission. Expected death within 24 hours The sublingual microcirculation cannot be measured

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucocorticoid combination therapy Group<br>Hydrocortisone 200mg continuous intravenous infusion(24h) combined with vitamin C1.5g intravenous infusion every 6 hours and vitamin B1 200mg intravenous infusion every 12 hours. | Drug: Glucocorticoid combination therapy<br>* Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.<br>* Other names: Hydrocortisone, vitamin C and vitamin B1;|
| Active Comparator: Glucocorticoid Group<br>Hydrocortisone 200mg continuous intravenous infusion(24h) | Drug: Glucocorticoid<br>* The glucocorticoid group was defined as the use of hydrocortisone alone.<br>* Other names: Hydrocortisone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfused vessel density (PVD) | Determinant of capillary diffusive capacity | 24 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of perfusion vessels | sublingual microcirculation parameter | 24 hours after treatment | 
| total vascular density | sublingual microcirculation parameter | 24 hours after treatment | 
| microvascular flow index | sublingual microcirculation parameter | 24 hours after treatment | 
| renal contrast-enhanced ultrasound parameters | renal perfusion | 24 hours after treatment | 
| lactate | Tissue perfusion parameter | 24 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septic shock, glucocorticoid, vitamin C, microcirculation, Vitamin B1