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

NCT ID: NCT03259594

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-12-31

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.

Conditions

Simple Renal Cyst

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

endophytic group

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.

Group Type: EXPERIMENTAL

Laparoscopic deroofing

Intervention Type: PROCEDURE

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.

100 g of amino acids supplementation

Intervention Type: DRUG

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

exophytic group

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.

Group Type: SHAM_COMPARATOR

Laparoscopic deroofing

Intervention Type: PROCEDURE

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.

100 g of amino acids supplementation

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

100 g of amino acids supplementation

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

Intervention Type: DRUG

Other Intervention Names

Compound Amino Acids Injection(18AA-Ⅶ)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ou tongwen

OTHER

Sponsor Role: lead

Responsible Party

ou tongwen

Head of Urology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tongwen Ou, MD.

Role: STUDY_CHAIR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenhua Shang, MD.

Role: CONTACT

shangzhenhua16@126.com

+8617801117318

Hao Yan, MD.

Role: CONTACT

+8683198448

Facility Contacts

Zhenhua Shang, MD.

Role: primary

Other Identifiers

otw-20170804-01

Identifier Type: -

Identifier Source: org_study_id