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

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Drug: Glucocorticoid combination therapy; Drug: Glucocorticoid

• Registration Number: NCT03821714
• Lead Sponsor: Southeast University, China

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.

Study Timeline

• Study First Submitted: 2019-01-19
• Study First Submitted QC: 2019-01-26
• Study First Posted: 2019-01-30
• Study Start: 2019-02-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-07
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucocorticoid combination therapy Group	Glucocorticoid combination therapy	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.
Glucocorticoid Group	Glucocorticoid	Hydrocortisone 200mg continuous intravenous infusion(24h)

Primary Outcome Measures

Name	Time	Method
Perfused vessel density (PVD)	24 hours after treatment	Determinant of capillary diffusive capacity

Secondary Outcome Measures

Name	Time	Method
lactate	24 hours after treatment	Tissue perfusion parameter
total vascular density	24 hours after treatment	sublingual microcirculation parameter
proportion of perfusion vessels	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

Trial Locations

Locations (1)

Nanjing Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China