Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers

Acute Kidney Injury Clinical Trial

Official title:

Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077007
• Other study ID #: FMASU R 77/ 2021
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2021
• Source: Ain Shams University
• Contact: waleed Mousa, MD
• Phone: +201067628771
• Email: waleedmousa2[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures

Description:

The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures and assess their usefulness as diagnostic biomarkers for AKI and the relationship between the selected RNA based biomarker panel and clinicopathological changes of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 1, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion criteria for patients :

1. Patients undergoing treatment for a stone(s) located in the kidney less than 2 cm

2. Radiopaque stone

3. Able and willing to give informed consent

Inclusion criteria for Healthy volunteers

1. No history of kidney or stone disease

2. Asymptomatic

3. No indwelling ureteral stent

4. Willing to provide medical history information

5. Able and willing to give informed consent

Exclusion Criteria:

• Exclusion criteria for patients

1. Active urinary tract infection

2. Bleeding disorder

3. Chronic renal failure (eGFR<30)

4. Ureteral stone

Related Conditions & MeSH terms

• Acute Kidney Injury
• Calculi
• Extracorporeal Shockwave Lithotripsy
• Kidney Calculi
• Nephrolithiasis
• Percutaneous Nephrolithotomy
• Renal Calculi

Intervention

Procedure:
• Percutaneous nephrolithotomy
Endoscopic stone Extraction from the kidney by making a puncture and dilate a tract direct into the kidney through muscle wall and renal parenchyma
• Extracorporeal Shock Wave Lithotripsy
Using Shock waves from outside the body targeted at a kidney stone causing the stone to fragment. The stones are broken into tiny pieces.

Locations

Country	Name	City	State
Egypt	Urology Department, Faculty of Medicine, Ain Shams University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Science,Technology & Innovation Funding Authority

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers	Evaluation of kidney injury after procedures PCNL and ESWL by measuring the change of the level of novel non-coding lnc-RNA profile in urine	Before the procedure by 2hours and after the procedure by 2 and 24 hours