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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821714
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : February 19, 2019
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 Phase 4

Detailed Description:
It is a prospective, randomized, double-blind controlled trial. The investigators enroll patients aged 18-80 years with severe septic shock. Severe septic shock was defined as 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 (experimental group). The microcirculation was monitored at 0-6 h, 24 h, and 72 h after patients enrollment. 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)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It is a prospective, randomized, double-blind controlled trial. We enroll patients aged 18-80 years with severe septic shock. Severe septic shock was defined as septic shock with norepinephrine >15ug/min. We randomly divided the patients into two groups: the glucocorticoid treatment group (control group), the glucocorticoid combined with vitamin C and vitamin B1 treatment group (experimental group). The microcirculation was monitored at 0-6 h, 24 h, and 72 h after patients enrollment. We 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Case screeners screen patients who meet the inclusion criteria. A researcher sign informed consent with family members or patients. Patients were divided into groups according to a random number table by screeners. Researchers collected sublingual microcirculation images and numbered in the order of grouping. Finally, the microcirculation images were analyzed by two other researchers, and the results were averaged. All researchers are not involved in clinical treatment.
Primary Purpose: Treatment
Official Title: Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 on Microcirculation in Severe Septic Shock
Estimated Study Start Date : February 20, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019


Arm Intervention/treatment
Experimental: Glucocorticoid combination therapy Group
The patients of the experimental group are treated with intravenous vitamin C (1.5 g every 6 h for 4 days or until ICU discharge), hydrocortisone (200 mg continuous intravenous injection in 24h for 3-5 days or until ICU discharge), as well as intravenous thiamine (200 mg every 12 h for 4 days or until ICU discharge).
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
The patients of the Glucocorticoid Group are treated with hydrocortisone (200 mg continuous intravenous injections in 24h for 3-5 days or until ICU discharge)
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: 1year ]
    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. Signing Informed Consent

Exclusion Criteria:

  1. Meet the inclusion criteria for more than 6 hours
  2. Pregnant
  3. Palliative treatment of patients
  4. Uncontrolled malignant tumors
  5. Glucocorticoid therapy was used within seven days before admission.
  6. Vitamin C was used within one month before admission.
  7. Vitamin B1 was used within three months before admission.
  8. Expected death within 24 hours

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


Contacts
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Contact: Jinglong Wang 18795851113 doctorwang2016@163.com
Contact: Yingzi Huang, PHD 13951693278 yz_huang@126.com

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, Principal Investigator, Southeast University, China
ClinicalTrials.gov Identifier: NCT03821714    
Other Study ID Numbers: 2018ZDSYLL057-P01
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
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
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