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

Southeast University, China

Status: Completed

Conditions: Septic Shock

Treatments: Drug: Glucocorticoid; Drug: Glucocorticoid combination therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03821714

2018ZDSYLL057-Y01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Glucocorticoid combination therapy Group

Experimental group

Description:

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.

Treatment:

Drug: Glucocorticoid combination therapy

Glucocorticoid Group

Active Comparator group

Description:

Hydrocortisone 200mg continuous intravenous infusion(24h)

Treatment:

Drug: Glucocorticoid