Skip to content

A multicentre, prospective, open, randomized clinical trial for the effect of high dose VC on prevention of urogenic sepsis in patients with upper urinary tract calculi

A multicentre, prospective, open, randomized clinical trial for the effect of high dose VC on prevention of urogenic sepsis in patients with upper urinary tract calculi

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052304
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-10-19
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Urosepsis

Interventions

experimental group:intravenous injection vitaminC (2g/d)
control group:intravenous injection normal saline (2g/d)

Sponsors

Guizhou Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. The age at the time of enrollment is 18-60 years old; 2. Patients with upper urinary tract calculi by abdominal CT examination and need PNCL treatment according to the treatment guidelines; 3. Blood leukocytes in (4-12) x 10^9/L; 4. Those who have not undergone surgery, radiotherapy or endocrine therapy; 5. ECOG score 0-2 and ASA I-III grade.; 6. The patient or the patient's authorized immediate family has signed the informed consent form for the clinical trial.

Exclusion criteria

Exclusion criteria: 1. There are contraindications to intravenous infusion of high-dose vitamin C, such as severe nausea and vomiting, severe arrhythmia (ventricular tachycardia, ventricular fibrillation) and other diseases that are not suitable for intravenous infusion of high-dose vitamin C: G6PD deficiency, paroxysmal sleep Hemoglobinuria; 2. Those diagnosed with SIRS; 3. Patients with blood system diseases such as anemia, hemophilia, leukemia; 4. Continued use of immunosuppressants or organ transplants and cancer patients within the past 6 months; 5. Patients with renal insufficiency and GFR < 30 ml/min, or patients with liver transaminase greater than 10 times the normal threshold; 6. Those who have participated in other clinical trials within 30 days; 7. Those with poor compliance and unable to follow up as planned.

Design outcomes

Primary

MeasureTime frame
body temperature;Heart rate;respiration rate;blood pressure;blood platelet count;bilirubin;dopamine;adrenaline;noradrenaline;creatinine;urine volume;clasgow coma score;

Secondary

MeasureTime frame
urine erythrocyte;Urine leukocyte;Urine bacteria;Urine nitrite;numeration of leukocyte;Neutrophil ratio;blood coagulation factor;procalcitonin;C-reactive protein;Abdominal X-ray;abdominal ultrasound scan;Intravenous urography;

Countries

China

Contacts

Public ContactJiang Kehua

Guizhou Provincial People's Hospital

4158273@qq.com+86 18585090768

Outcome results

None listed

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