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

Primary Purpose

Septic Shock

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Glucocorticoid combination therapy
Glucocorticoid
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring septic shock, glucocorticoid, vitamin C, microcirculation, Vitamin B1

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing Zhongda Hospital, Southeast University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glucocorticoid combination therapy Group

Glucocorticoid Group

Arm Description

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.

Hydrocortisone 200mg continuous intravenous infusion(24h)

Outcomes

Primary Outcome Measures

Perfused vessel density (PVD)
Determinant of capillary diffusive capacity

Secondary Outcome Measures

proportion of perfusion vessels
sublingual microcirculation parameter
total vascular density
sublingual microcirculation parameter
microvascular flow index
sublingual microcirculation parameter
renal contrast-enhanced ultrasound parameters
renal perfusion
lactate
Tissue perfusion parameter

Full Information

First Posted
January 19, 2019
Last Updated
October 7, 2023
Sponsor
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT03821714
Brief Title
Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 on Microcirculation in Severe Septic Shock
Official Title
Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 Versus Hydrocortisone Alone on Microcirculation in Severe Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
septic shock, glucocorticoid, vitamin C, microcirculation, Vitamin B1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucocorticoid combination therapy Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Glucocorticoid Group
Arm Type
Active Comparator
Arm Description
Hydrocortisone 200mg continuous intravenous infusion(24h)
Intervention Type
Drug
Intervention Name(s)
Glucocorticoid combination therapy
Other Intervention Name(s)
Hydrocortisone, vitamin C and vitamin B1
Intervention Description
Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.
Intervention Type
Drug
Intervention Name(s)
Glucocorticoid
Other Intervention Name(s)
Hydrocortisone
Intervention Description
The glucocorticoid group was defined as the use of hydrocortisone alone.
Primary Outcome Measure Information:
Title
Perfused vessel density (PVD)
Description
Determinant of capillary diffusive capacity
Time Frame
24 hours after treatment
Secondary Outcome Measure Information:
Title
proportion of perfusion vessels
Description
sublingual microcirculation parameter
Time Frame
24 hours after treatment
Title
total vascular density
Description
sublingual microcirculation parameter
Time Frame
24 hours after treatment
Title
microvascular flow index
Description
sublingual microcirculation parameter
Time Frame
24 hours after treatment
Title
renal contrast-enhanced ultrasound parameters
Description
renal perfusion
Time Frame
24 hours after treatment
Title
lactate
Description
Tissue perfusion parameter
Time Frame
24 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Septic shock A dose of norepinephrine (>15ug/min) Age ≥18 and ≤80 years old Signing Informed Consent Exclusion Criteria: Meet the inclusion criteria for more than 12 hours Clinician judges that corticosteroid therapy should not be used Pregnant Uncontrolled malignancy Glucocorticoid therapy was used within seven days before admission. Expected death within 24 hours The sublingual microcirculation cannot be measured
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingyuan Xu, PhD
Organizational Affiliation
Southeast University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Zhongda Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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