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

Not Applicable

• Conditions: Simple Renal Cyst
• Interventions: Procedure: Laparoscopic deroofing; Drug: 100 g of amino acids supplementation

• Registration Number: NCT03259594
• Lead Sponsor: ou tongwen

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-23
• Study Start: 2018-03-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-04-29
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exophytic group	Laparoscopic deroofing	participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
exophytic group	100 g of amino acids supplementation	participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
endophytic group	Laparoscopic deroofing	participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
endophytic group	100 g of amino acids supplementation	participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.

Primary Outcome Measures

Name	Time	Method
Change in renal functional reserve after laparoscopic deroofing	1 month after surgery.	1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.

Trial Locations

Locations (1)

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China