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Effect of high dose Vitamin C in the treatment of sepsis: a randomized, double-blind, multi-centre clinical trial

Protective effect of high dose intravenous Vitamin C on the multi organs function in the early stage of sepsis: a randomized, double-blind, multi-centre clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017633
Enrollment
Unknown
Registered
2018-08-07
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

sepsis

Interventions

Vit C group:continuos intravenous injection of Vitamin C with 200 mg/kg/h for 4 days
NS group:continuos intravenous injection of normal saline using the same dose as Vit C for 4 days

Sponsors

Department of emergency, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 year; 2. Meeting the diagnostic criteria for sepsis; 3. Onset within 72 hours; 4. avoiding to be pregnant in the whole period; 5. Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. In the processing of treatment of tumor; 2. refusal of organ support therapy such as renal replacement therapy, vasoactive agents and mechanical ventilation; 3. in the period of pregnant or lactation; 4. with chronic ardiovascular, hepatic, respiratory or renal dysfunction before admission; chronic cardiovascular dysfunction requiring home mechanical hemodynamic support (e.g., ventricular assist device) or home chemical hemodynamic support (e.g., milrinone); chronic hepatic dysfunction requiring child-pugh C; chronic respiratory dysfunction requiring supplemental noninvasive oxygen via nasal cannula or NIPPV; chronic kidney disease requiring eGFR 150umol/L; 5. known kidney stone; 6. known allergy to vitamin C; 7. involved in other clinical trial; 8. use of immunosuppressants or glucocorticoids for more than two weeks (equivalent to 0.5 mg/kg prednisone or prednisolone), especially for autoimmune diseases or organ transplantation; 9. body weight>100kg.

Design outcomes

Primary

MeasureTime frame
28 days mortality;

Secondary

MeasureTime frame
indication for organ function(liver,kidney,heart,lung,coagulation);sequential organ failure assessment (SOFA) score;VitC related adverse event (urine crystal, urine volume per day,indicatiors for kidney function);period for ventilation;period for renal replacement therapy;period for vasoactive agents application;plasma level of VitaminC;

Countries

China

Contacts

Public ContactMao Enqiang

Department of emergency, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

maoeq@yeah.net+86 13501747906

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026