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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03821714
• Other study ID #: 2018ZDSYLL057-Y01
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: October 2023
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 30, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Glucocorticoid combination therapy
Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.
• Glucocorticoid
The glucocorticoid group was defined as the use of hydrocortisone alone.

Locations

Country	Name	City	State
China	Nanjing Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfused vessel density (PVD)	Determinant of capillary diffusive capacity	24 hours after treatment
Secondary	proportion of perfusion vessels	sublingual microcirculation parameter	24 hours after treatment
Secondary	total vascular density	sublingual microcirculation parameter	24 hours after treatment
Secondary	microvascular flow index	sublingual microcirculation parameter	24 hours after treatment
Secondary	renal contrast-enhanced ultrasound parameters	renal perfusion	24 hours after treatment
Secondary	lactate	Tissue perfusion parameter	24 hours after treatment