Sonographic Examination of Renal Function in Individuals with Long-term Spinal Cord Injury

Completed

• Conditions: Spinal Cord Injuries; Renal Insufficiency
• Interventions: Diagnostic Test: renal scintigraphy; Diagnostic Test: renal doppler sonography

• Registration Number: NCT04241666
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

Brief Summary

Patients with long-term lower urinary tract dysfunction due to spinal cord injury presenting for a routine urodynamic control will be screened for inclusion and exclusion criteria. Suitable individuals providing written informed consent will undergo renal Doppler sonography and renal scintigraphy in addition to the routine examinations. Conclusions regarding renal function based on the clearance rate determined by scintigraphy (gold standard) will be compared with the conclusions based on Doppler sonography and Cystatin C clearance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Study Start: 2022-01-05
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• long-term spinal cord injury (≥10 years)
• age ≥30 years
• written informed consent

Exclusion Criteria

• dementia or severe intellectual impairment
• serious internal illness
• previous or current tumor disease
• known allergy to the radioactive marker (Technetium)
• pregnancy or breastfeeding
• withdrawal of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal renal function	renal doppler sonography	individuals with renal clearance \>89 ml/min/1.73m²
normal renal function	renal scintigraphy	individuals with renal clearance \>89 ml/min/1.73m²
mild renal insufficiency	renal doppler sonography	individuals with renal clearance 60-89 ml/min/1.73m²
moderate renal insufficiency	renal scintigraphy	individuals with renal clearance 30-59 ml/min/1.73m²
mild renal insufficiency	renal scintigraphy	individuals with renal clearance 60-89 ml/min/1.73m²
moderate renal insufficiency	renal doppler sonography	individuals with renal clearance 30-59 ml/min/1.73m²

Primary Outcome Measures

Name	Time	Method
renal clearance	at the time of inclusion into study	renal clearance of Technetium-99m-dimercaptosuccinic acid determined by scintigraphy

Secondary Outcome Measures

Name	Time	Method
Cystatin C concentration	at the time of inclusion into study	blood serum concentration of Cystatin C (mg/L)
Cystatin C clearance	at the time of inclusion into study	renal clearance of Cystatin C (ml/min) according to the Grubb formula
renal peak systolic velocity	at the time of inclusion into study	Doppler sonography evaluation of renal blood flow during systolic heart phase (m/s)
renal peak enddiastolic velocity	at the time of inclusion into study	Doppler sonography evaluation of renal blood flow during enddiastolic heart phase (m/s)
renal resistive index	at the time of inclusion into study	(systolic velocity - enddiastolic velocity) / systolic velocity

Trial Locations

Locations (1)

Swiss Paraplegic Centre; 🇨🇭 Nottwil, LU, Switzerland