NCT03821714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

January 19, 2019

Last Update Submit

October 7, 2023

Conditions

Septic Shock

Keywords

septic shockglucocorticoidvitamin CmicrocirculationVitamin B1

Outcome Measures

Primary Outcomes (1)

  • Perfused vessel density (PVD)

    Determinant of capillary diffusive capacity

    24 hours after treatment

Secondary Outcomes (5)

  • proportion of perfusion vessels

    24 hours after treatment

  • total vascular density

    24 hours after treatment

  • microvascular flow index

    24 hours after treatment

  • renal contrast-enhanced ultrasound parameters

    24 hours after treatment

  • lactate

    24 hours after treatment

Study Arms (2)

Glucocorticoid combination therapy Group

EXPERIMENTAL

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 Group

ACTIVE COMPARATOR

Hydrocortisone 200mg continuous intravenous infusion(24h)

Drug: Glucocorticoid

Interventions

Glucocorticoid combination therapyDRUG

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

Also known as: Hydrocortisone, vitamin C and vitamin B1
Glucocorticoid combination therapy Group
GlucocorticoidDRUG

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

Also known as: Hydrocortisone
Glucocorticoid Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

HydrocortisoneAscorbic AcidThiamineGlucocorticoids

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Jingyuan Xu, PhD

    Southeast University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 19, 2019

First Posted

January 30, 2019

Study Start

February 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 30, 2020

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)