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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-01-30

Brief Summary

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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.

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Detailed Description

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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

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Glucocorticoid combination therapy

Intervention Type DRUG

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

Glucocorticoid Group

Hydrocortisone 200mg continuous intravenous infusion(24h)

Group Type ACTIVE_COMPARATOR

Glucocorticoid

Intervention Type DRUG

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

Interventions

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Glucocorticoid combination therapy

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

Intervention Type DRUG

Glucocorticoid

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

Intervention Type DRUG

Other Intervention Names

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Hydrocortisone, vitamin C and vitamin B1 Hydrocortisone

Eligibility Criteria

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Inclusion Criteria

1. Septic shock
2. A dose of norepinephrine (\>15ug/min)
3. Age ≥18 and ≤80 years old
4. Signing Informed Consent

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No