NCT03821714

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	Glucocorticoid combination therapy	Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.
DRUG	Glucocorticoid	The glucocorticoid group was defined as the use of hydrocortisone alone.

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-01-01
• Completion: 2020-01-30
• First posted: 2019-01-30
• Last updated: 2023-10-10

Locations

1 site across 1 country: China