A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.

Xuhui Central Hospital, Shanghai

Status and phase: Unknown; Phase 4

Conditions: Hypouricemia, Renal; Urolithiasis

Treatments: Drug: Febuxostat 40mg Tab; Behavioral: Non-drug control group

Study type: Interventional

Funder types: Other

Identifiers

NCT04398251

2020-043

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• .Over 18 years old, under 70 years old, regardless of sex .The subjects had no mental illness or language dysfunction, could understand the situation of this study and had signed an informed consent form.

.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.

• Serum uric acid value ≥480 µmol / L
• urinary stones

Exclusion criteria

• Transplanted kidney
• Fever or urinary tract infection is not treated according to the inclusion criteria
• Pregnant women and female menstruation
• Unable to tolerate anesthesia or surgery due to severe systemic disease, heart disease, pulmonary insufficiency and important organ failure
• Patients with renal insufficiency Clcr <30 mL/min
• Those who take side effects of febuxostat，Patients with side effects of febuxostat, patients with a previous history of coronary heart disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Uric acid drug control group

Experimental group

Description:

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

Treatment:

Drug: Febuxostat 40mg Tab

Non-drug control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Non-drug control group