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

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ClinicalTrials.gov Identifier: NCT03259594
Recruitment Status : Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
ou tongwen, Xuanwu Hospital, Beijing

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

Condition or disease Intervention/treatment Phase
Simple Renal Cyst Procedure: Laparoscopic deroofing Drug: 100 g of amino acids supplementation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to two groups.One group participants are with endophytic simple renal cysts, and the other are with exophytic simple renal cysts.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measurement of Renal Functional Reserve Change In Patients With Simple Renal Cysts Before and After Laparoscopic Deroofing
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.
Other Name: Compound Amino Acids Injection(18AA-Ⅶ)

Sham Comparator: 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.
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.
Other Name: Compound Amino Acids Injection(18AA-Ⅶ)




Primary Outcome Measures :
  1. Change in renal functional reserve after laparoscopic deroofing [ Time Frame: 1 month after surgery. ]
    1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259594


Contacts
Contact: Zhenhua Shang, MD. +8617801117318 shangzhenhua16@126.com
Contact: Hao Yan, MD. +8683198448

Locations
China, Beijing
Xuanwu Hospital Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100053
Contact: Zhenhua Shang, MD.         
Sponsors and Collaborators
ou tongwen
Investigators
Study Chair: Tongwen Ou, MD. Xuanwu Hospital, Beijing

Responsible Party: ou tongwen, Head of Urology, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03259594     History of Changes
Other Study ID Numbers: otw-20170804-01
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ou tongwen, Xuanwu Hospital, Beijing:
Renal functional reserve
Simple renal cysts
Laparoscopic deroofing