A Phase 4 interventional study of Febuxostat 40mg Tab and Non-drug control group in Hypouricemia, Renal and Urolithiasis, sponsored by Xuhui Central Hospital, Shanghai. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-21.
Sponsored by Xuhui Central Hospital, Shanghai · Phase 4, Interventional, and Prevention
The purpose of this study was to explore the effects of uric acid control on stone recurrence and renal function in patients with calculi of hyperuricemia through a prospective controlled study.
2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). The patients were followed up for 3 months, 6 months, 12 months and 18 months after operation.
Informations as age, sex, height, weight, calculation BMI, past medical history, history of gout, diabetes, hyperthyroidism, calcium supplements will be recorded.
Rapid blood glucose, serum total cholesterol, high density cholesterol, thyroid hormone detection, androgen, estrogen detection, serum sodium, potassium, chlorine, calcium, magnesium, phosphorus, serum uric acid will be tested.
Renogram test to evaluate the change of single renal function. The stones burden will be followed-up with ultrasound or kub or CT plain scan.
278 studies on the registry are indexed under Urolithiasis; 70 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 197 interventional studies indexed under Urolithiasis.
Browse Urolithiasis studies →Xuhui Central Hospital, Shanghai is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
.No clinical manifestations of urinary tract infection, urinary routine examination showed urinary tract infection, but urinary etiology test was negative (urinary routine leukocytosis), treated with broad-spectrum antibiotics for more than 3 days.
.Clinical manifestations of urinary tract infection, urine routine examination showed urinary tract infection, and patients with positive urinary etiology were treated with sensitive antibiotics for more than 7 days.
Exclusion Criteria:
For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week
Drug: Febuxostat 40mg Tab
They are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly.
Behavioral: Non-drug control group
For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week.
All patients in the group are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Time frame: Change from the base line of the stone's volume and quantity at 3 months.
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Time frame: Change from the base line of the stone's volume and quantity at 6 months.
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Time frame: Change from the base line of the stone's volume and quantity at 12 months.
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Time frame: Change from the base line of the stone's volume and quantity at 18 months.
Renal function
Total and partial renal function
Time frame: Change from the base line of GFR at 6 months after the operation.
Renal function
Total and partial renal function
Time frame: Change from the base line of GFR at 12 months after the operation.
Renal function
Total and partial renal function
Time frame: Change from the base line of GFR at 18 months after the operation.
Serum uric acid level
Serum uric acid level
Time frame: Chage from the base line at 3 months after the operation
Serum uric acid level
Serum uric acid level
Time frame: Chage from the base line at 6 months after the operation
Serum uric acid level
Serum uric acid level
Time frame: Chage from the base line at 12 months after the operation
Serum uric acid level
Serum uric acid level
Time frame: Chage from the base line at 18 months after the operation
Plan to share: No — Subject information, test results
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Xuhui Central Hospital, Shanghai