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

Sponsor

Southeast University, China (Other)

Overall Status

Completed

CT.gov ID

NCT03821714

Collaborator

(none)

Enrollment

Location

Arms

11.9

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock	Drug: Glucocorticoid combination therapy Drug: Glucocorticoid	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glucocorticoid combination therapy Group 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 Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1. Other Names: Hydrocortisone, vitamin C and vitamin B1
Active Comparator: Glucocorticoid Group Hydrocortisone 200mg continuous intravenous infusion(24h)	Drug: Glucocorticoid The glucocorticoid group was defined as the use of hydrocortisone alone. Other Names: Hydrocortisone

Arm

Intervention/Treatment

Experimental: Glucocorticoid combination therapy Group

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

Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.

Other Names:

Hydrocortisone, vitamin C and vitamin B1

Active Comparator: Glucocorticoid Group

Hydrocortisone 200mg continuous intravenous infusion(24h)

Drug: Glucocorticoid

The glucocorticoid group was defined as the use of hydrocortisone alone.

Other Names:

Hydrocortisone

Outcome Measures

Primary Outcome Measures

Perfused vessel density (PVD) [24 hours after treatment]
Determinant of capillary diffusive capacity

Secondary Outcome Measures

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