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

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Glucocorticoid combination therapy; Drug: Glucocorticoid

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Zhongda Hospital, Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfused vessel density (PVD)	Determinant of capillary diffusive capacity	24 hours after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of perfusion vessels	sublingual microcirculation parameter	24 hours after treatment
total vascular density	sublingual microcirculation parameter	24 hours after treatment
microvascular flow index	sublingual microcirculation parameter	24 hours after treatment
renal contrast-enhanced ultrasound parameters	renal perfusion	24 hours after treatment
lactate	Tissue perfusion parameter	24 hours after treatment

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Principal Investigator: Jingyuan Xu, PhD, Southeast university

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: January 26, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: septic shock; microcirculation; Vitamin B1; glucocorticoid; vitamin C
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Physiological Effects of Drugs; Anti-Inflammatory Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Micronutrients; Vitamins; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Glucocorticoids
• Other Study ID Numbers: 2018ZDSYLL057-Y01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No