Septic ShockNCT03821714
Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 on Microcirculation in Severe Septic Shock
A study testing Glucocorticoid combination therapy and Glucocorticoid in people with Septic Shock, run by Southeast University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Glucocorticoid combination therapy and Glucocorticoid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septic shock
- A dose of norepinephrine (>15ug/min)
- Age ≥18 and ≤80 years old
- Signing Informed Consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210000
About this study
Official title: 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.
Read the 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.
- Conditions
- Septic Shock
- Being tested
- Glucocorticoid combination therapy, Glucocorticoid
- Keywords
- septic shock, glucocorticoid, vitamin C, microcirculation, Vitamin B1
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucocorticoid combination therapyDrug
Also called Hydrocortisone, vitamin C and vitamin B1
Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.
GlucocorticoidDrug
Also called Hydrocortisone
The glucocorticoid group was defined as the use of hydrocortisone alone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Glucocorticoid combination therapy |
| Glucocorticoid Group | Active comparator | Hydrocortisone 200mg continuous intravenous infusion(24h) Receives: Drug: Glucocorticoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfused vessel density (PVD)
Determinant of capillary diffusive capacity
Measured: 24 hours after treatment
Secondary outcomes (5)
proportion of perfusion vessels
sublingual microcirculation parameter
Measured: 24 hours after treatment
total vascular density
sublingual microcirculation parameter
Measured: 24 hours after treatment
microvascular flow index
sublingual microcirculation parameter
Measured: 24 hours after treatment
renal contrast-enhanced ultrasound parameters
renal perfusion
Measured: 24 hours after treatment
lactate
Tissue perfusion parameter
Measured: 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Feb 2019
- Primary completion1 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Jingyuan Xu, PhD, Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821714
- Sponsor's protocol ID
- 2018ZDSYLL057-Y01
- Status last verified
- Oct 2023
- First submitted
- 19 Jan 2019
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 Versus Hydrocortisone Alone on Microcirculation in Severe Septic Shock
- ClinicalTrials.gov ID
- NCT03821714
- Acronym / sponsor ID
- 2018ZDSYLL057-Y01
- Conditions
- Septic Shock
- Keywords
- septic shock, glucocorticoid, vitamin C, microcirculation, Vitamin B1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoid combination therapy Group | Experimental | Drug: Glucocorticoid combination therapyHydrocortisone 200mg continuous intravenous infusion(24h) combined with vitamin C1.5g intravenous infusion every 6 hours and vitamin B1 200mg intravenous infusion every 12 hours. |
| Glucocorticoid Group | Active comparator | Drug: GlucocorticoidHydrocortisone 200mg continuous intravenous infusion(24h) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Septic shock
- A dose of norepinephrine (>15ug/min)
- Age ≥18 and ≤80 years old
- Signing Informed Consent
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucocorticoid combination therapyAlso: Hydrocortisone, vitamin C and vitamin B1Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1. | Drug | Glucocorticoid combination therapy Group |
| GlucocorticoidAlso: HydrocortisoneThe glucocorticoid group was defined as the use of hydrocortisone alone. | Drug | Glucocorticoid Group |
Primary outcome
Perfused vessel density (PVD)
Time frame: 24 hours after treatment
Determinant of capillary diffusive capacity
5 secondary outcomes
proportion of perfusion vessels
Time frame: 24 hours after treatment
total vascular density
Time frame: 24 hours after treatment
microvascular flow index
Time frame: 24 hours after treatment
renal contrast-enhanced ultrasound parameters
Time frame: 24 hours after treatment
lactate
Time frame: 24 hours after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingyuan Xu, PhD principal investigator
Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucocorticoid combination therapy and Glucocorticoid in people with Septic Shock, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfused vessel density (PVD) (time frame: 24 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.