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

Urolithiasis Clinical Trial

Official title:

Department of Urology, Shanghai Xu-hui Central Hospital

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04398251
• Other study ID #: 2020-043
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: April 10, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2020
• Source: Xuhui Central Hospital, Shanghai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: May 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypouricemia, Renal
• Urolithiasis

Intervention

Drug:
• Febuxostat 40mg Tab
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.

Behavioral:
• Non-drug control group
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

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xuhui Central Hospital, Shanghai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum uric acid level	Serum uric acid level	Chage from the base line at 3 months after the operation
Other	Serum uric acid level	Serum uric acid level	Chage from the base line at 6 months after the operation
Other	Serum uric acid level	Serum uric acid level	Chage from the base line at 12 months after the operation
Other	Serum uric acid level	Serum uric acid level	Chage from the base line at 18 months after the operation
Primary	Stone burdern stone burdern	Use ultrasound or kub or CT plain scan to follow up the patients.	Change from the base line of the stone's volume and quantity at 3 months.
Primary	Stone burdern stone burdern	Use ultrasound or kub or CT plain scan to follow up the patients.	Change from the base line of the stone's volume and quantity at 6 months.
Primary	Stone burdern stone burdern	Use ultrasound or kub or CT plain scan to follow up the patients.	Change from the base line of the stone's volume and quantity at 12 months.
Primary	Stone burdern stone burdern	Use ultrasound or kub or CT plain scan to follow up the patients.	Change from the base line of the stone's volume and quantity at 18 months.
Secondary	Renal function	Total and partial renal function	Change from the base line of GFR at 6 months after the operation.
Secondary	Renal function	Total and partial renal function	Change from the base line of GFR at 12 months after the operation.
Secondary	Renal function	Total and partial renal function	Change from the base line of GFR at 18 months after the operation.