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Hydrocortisone, Vitamin C, and Thiamine for the treatment of septic shock

Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock(ThyVic study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018138
Enrollment
Unknown
Registered
2018-09-01
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

septic shock

Interventions

Treatment Group:Hydrocortisone, Vitamin C, and Thiamine
Control Group:normal saline

Sponsors

The First College of Clinical Medical Science, China Three Gorges University, Yichang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM); 2. Aged over 18 years; 3. ICU stay =96h; 4. obtain informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant; 2. do not resuscitate (DNR) or do not intubate (DNI) orders; 3. Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency; 4. Clinical indication for thiamine as determined by the clinical team providing this drug 5. Clinical indication for steroids (e.g. chronic use) as determined by the clinical team providing this drug; 6. Attended other clinical study in past 60 days. 1. There are contraindications for intravenous infusion of high-dose of vitamin c, such as severe nausea and vomiting, severe arrhythmia (VT, VF) as well as G6PD deficiency, PNH; 2. The estimated survival time <96h; 3. CRRT within the stay of the first 96h; 4. Previous immunodepressant within 6 months before study entry or Receipt of a solid-organ or bone marrow transplant; 5. Previous glucocorticosteroid within 7 days before study entry, more than Methylprednisolone (or convert to Methylprednisolone) =20mg/day; 6. Participation in an investigational clinical trial within 30 days; 7. Cannot finish the study (Expected survival < 96 hours or refuse treatment).

Design outcomes

Primary

MeasureTime frame
Mortality;Delta of Sequential Organ Failure Assessment (SOFA) score at 72 hours;—

Secondary

MeasureTime frame
Lactate clearance;duration of vasopressor therapy;incidence of AKI;requirement for renal replacement therapy in participants with Acute kidney injury(AKI);PCT clearance at 72h;White BLood Cell in CBC;Platelet;serum CRP;serum vitamin C;—

Contacts

Public ContactZhaohui Zhang

The First College of Clinical Medical Science, China Three Gorges University, Yichang Central People Hospital

15071737290@163.com+86 15071737290

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026