Back to results

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

Primary Purpose

Simple Renal Cyst

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Laparoscopic deroofing

100 g of amino acids supplementation

About this trial

This is an interventional treatment trial for Simple Renal Cyst focused on measuring Renal functional reserve, Simple renal cysts, Laparoscopic deroofing

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18
Estimated GFR >30 mL/min/1.73m2
Subjects who signed informed consent forms

Exclusion Criteria:

Allergy to iothalamate, shellfish or iodine
Use of metformin or amiodarone
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)
Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
Inadequate intravenous access
Severe anemia (Hct <21%)
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)
History of contrast-induced nephropathy
Hyperthyroidism
Pheochromocytoma
Sickle cell disease
Urinary retention or incontinence
Status post organ transplant
Pregnancy or active breast feeding
Cognitive impairment with inability to give consent
Institutionalized status

Sites / Locations

Xuanwu Hospital Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

endophytic group

exophytic group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03259594

First Posted

August 21, 2017

Last Updated

April 27, 2020

Sponsor

ou tongwen

1. Study Identification

Unique Protocol Identification Number

NCT03259594

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

ou tongwen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Simple Renal Cyst

Keywords

Renal functional reserve, Simple renal cysts, Laparoscopic deroofing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

endophytic group

Arm Type

Experimental

Arm Description

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.

Arm Title

exophytic group

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic deroofing

Intervention Description

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

Drug

Intervention Name(s)

100 g of amino acids supplementation

Other Intervention Name(s)

Compound Amino Acids Injection(18AA-Ⅶ)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in renal functional reserve after laparoscopic deroofing

Description

1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.

Time Frame

1 month after surgery.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 Estimated GFR >30 mL/min/1.73m2 Subjects who signed informed consent forms Exclusion Criteria: Allergy to iothalamate, shellfish or iodine Use of metformin or amiodarone 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) Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim) Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy Inadequate intravenous access Severe anemia (Hct <21%) 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) History of contrast-induced nephropathy Hyperthyroidism Pheochromocytoma Sickle cell disease Urinary retention or incontinence Status post organ transplant Pregnancy or active breast feeding Cognitive impairment with inability to give consent Institutionalized status

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhenhua Shang, MD.

Phone

+8617801117318

shangzhenhua16@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hao Yan, MD.

Phone

+8683198448

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tongwen Ou, MD.

Organizational Affiliation

Xuanwu Hospital, Beijing

Official's Role

Study Chair

Facility Information:

Facility Name

Xuanwu Hospital Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhenhua Shang, MD.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs