Measurement of Renal Functional Reserve Change In Patients With SRC Before and After Laparoscopic Deroofing

Simple Renal Cyst Clinical Trial

Official title:

Measurement of Renal Functional Reserve Change In Patients With Simple Renal Cysts Before and After Laparoscopic Deroofing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03259594
• Other study ID #: otw-20170804-01
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2020
• Source: Xuanwu Hospital, Beijing
• Contact: Zhenhua Shang, MD.
• Phone: +8617801117318
• Email: shangzhenhua16[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Renal functional reserve may be improved in patients with simple renal cysts after laparoscopic deroofing.

Description:

Simple renal cysts (SRC) are the most frequent type of cystic renal disease. The prevalence rate of SRCs is about 10% and increases with age. Hypertension and decreased renal functions have been reported to occur more commonly among these patients with SRC and there are no clear guidelines for managing asymptomatic SRCs.Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).The investigators hypothesized that RFR may be improved in some patients with simple renal cysts after laparoscopic deroofing despite identical resting glomerular filtration rate (rGFR).The aim of this study is to examine whether there is improvement of RFR in patients with simple renal cysts after laparoscopic deroofing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age =18

2. Estimated GFR >30 mL/min/1.73m2

3. Subjects who signed informed consent forms

Exclusion Criteria:

1. Allergy to iothalamate, shellfish or iodine

2. Use of metformin or amiodarone

3. Inability to maintain a stable regimen of medications which affect GFR for > one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)

4. Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)

5. Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy

6. Inadequate intravenous access

7. Severe anemia (Hct <21%)

8. Acute kidney injury (rise in creatinine to =1.5 times the previous baseline or by = 0.3 mg/dL on most recent labs prior to enrollment)

9. History of contrast-induced nephropathy

10. Hyperthyroidism

11. Pheochromocytoma

12. Sickle cell disease

13. Urinary retention or incontinence

14. Status post organ transplant

15. Pregnancy or active breast feeding

16. Cognitive impairment with inability to give consent

17. Institutionalized status

Related Conditions & MeSH terms

• Cysts
• Simple Renal Cyst

Intervention

Procedure:
• Laparoscopic deroofing
The classic treatment of patients with simple renal cysts is deroofing, which can be performed by open surgery or laparoscopy. Laparoscopic deroofing is an effective minimally invasive approach and has gained popularity.

Drug:
• 100 g of amino acids supplementation
intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.

Locations

Country	Name	City	State
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
ou tongwen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in renal functional reserve after laparoscopic deroofing	1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.	1 month after surgery.