Clinical trial NCT04398251: A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.
Official title: Department of Urology, Shanghai Xu-hui Central Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypouricemia, Renal
Urolithiasis
Keywords: Stone prevention
Renal function
Febuxostat
Lead sponsor: Xuhui Central Hospital, Shanghai
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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).

For non-drug control group: Patients 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.

Uric acid drug control group:or 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 20 mg three times a week
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stone burdern stone burdern
timeFrame: Change from the base line of the stone's volume and quantity at 3 months.
measure: Stone burdern stone burdern
timeFrame: Change from the base line of the stone's volume and quantity at 6 months.
measure: Stone burdern stone burdern
timeFrame: Change from the base line of the stone's volume and quantity at 12 months.
measure: Stone burdern stone burdern
timeFrame: Change from the base line of the stone's volume and quantity at 18 months.
Secondary outcomes:
measure: Renal function
timeFrame: Change from the base line of GFR at 6 months after the operation.
measure: Renal function
timeFrame: Change from the base line of GFR at 12 months after the operation.
measure: Renal function
timeFrame: Change from the base line of GFR at 18 months after the operation.
Other outcomes:
measure: Serum uric acid level
timeFrame: Chage from the base line at 3 months after the operation
measure: Serum uric acid level
timeFrame: Chage from the base line at 6 months after the operation
measure: Serum uric acid level
timeFrame: Chage from the base line at 12 months after the operation
measure: Serum uric acid level
timeFrame: Chage from the base line at 18 months after the operation
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
affiliation: Department of Urology, Zhongshan Hospital, Shanghai
name: JianMing Guo, PHD,M.D
role: STUDY_CHAIR
References: