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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821714
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Jingyuan,Xu, Southeast University, China

Brief Summary:
This study aimed to investigate the effect of Glucocorticoid combined with vitamin C and vitamin B1 on microcirculation in severe septic shock.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Glucocorticoid combination therapy Drug: Glucocorticoid Not Applicable

Detailed Description:
It is a prospective, randomized, double-blind controlled trial. The investigators enrolled patients aged 18-80 years with severe septic shock. Severe septic shock was defined as a septic shock with norepinephrine >15ug/min. The investigators randomly divided the patients into two groups: the glucocorticoid treatment group (control group), the glucocorticoid combined with vitamin C and vitamin B1 treatment group (treatment group). The microcirculation was monitored at 0h(baseline), 4 h, and 24h after treatment. The investigators monitored the sublingual microcirculatory alterations by Hand-held vital microscopes and scored the collected images according to the recommendations of the consensus on microcirculation monitoring in 2018. During the experiment, researchers, Microcirculation Image analysts, and patients were blinded to the treatment group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 on Microcirculation in Severe Septic Shock
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 30, 2020


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 Name: 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 Name: Hydrocortisone




Primary Outcome Measures :
  1. Perfused vessel density (PVD) [ Time Frame: 24 hours after treatment ]
    Determinant of capillary diffusive capacity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Palliative treatment of patients
  5. Uncontrolled malignant tumors
  6. Glucocorticoid therapy was used within seven days before admission.
  7. Expected death within 24 hours
  8. The sublingual microcirculation cannot be measured

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821714


Locations
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China, Jiangsu
Nanjing Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Southeast University, China
Investigators
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Principal Investigator: Jingyuan Xu, PhD Southeast University
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Responsible Party: Jingyuan,Xu, Clinical Professor, Southeast University, China
ClinicalTrials.gov Identifier: NCT03821714    
Other Study ID Numbers: 2018ZDSYLL057-P01
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jingyuan,Xu, Southeast University, China:
septic shock
glucocorticoid
vitamin C
microcirculation
Vitamin B1
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Vitamins
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Glucocorticoids
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists