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

Comparison of Sonographic Examination of Renal Function With Gold-standard Examination in Individuals With Long-term Spinal Cord Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04241666
Enrollment
50
Registered
2020-01-27
Start date
2022-01-05
Completion date
2025-01-31
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency, Spinal Cord Injuries

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.

Interventions

DIAGNOSTIC_TESTrenal scintigraphy

Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys

DIAGNOSTIC_TESTrenal doppler sonography

doppler ultrasound of both kidneys

Sponsors

Lotte und Adolf Hotz-Sprenger Stiftung
CollaboratorUNKNOWN
Swiss Paraplegic Research, Nottwil
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
renal clearanceat the time of inclusion into studyrenal clearance of Technetium-99m-dimercaptosuccinic acid determined by scintigraphy

Secondary

MeasureTime frameDescription
Cystatin C concentrationat the time of inclusion into studyblood serum concentration of Cystatin C (mg/L)
Cystatin C clearanceat the time of inclusion into studyrenal clearance of Cystatin C (ml/min) according to the Grubb formula
renal peak systolic velocityat the time of inclusion into studyDoppler sonography evaluation of renal blood flow during systolic heart phase (m/s)
renal peak enddiastolic velocityat the time of inclusion into studyDoppler sonography evaluation of renal blood flow during enddiastolic heart phase (m/s)
renal resistive indexat the time of inclusion into study(systolic velocity - enddiastolic velocity) / systolic velocity

Other

MeasureTime frameDescription
size of kidneysat the time of inclusion into studysize of kidneys evaluated by sonography
ageat the time of inclusion into studytime from birth to inclusion into study (years)
renal tissue echogenicityat the time of inclusion into studyrenal tissue echogenicity evaluated by sonography
bladder evacuation methodat the time of inclusion into studymethod of bladder evacuation
lesion level1 year after spinal cord injuryhighest intact spinal cord segment
lesion severity1 year after spinal cord injuryseverity of spinal cord injury according to American Spinal Injury Association Impairment Score (AIS) (A = motor and sensory complete, B = motor complete and sensory incomplete, C & D = motor and sensory incomplete, E = motor and sensory intact)
duration of spinal cord injuryat the time of inclusion into studytime from spinal cord injury to inclusion into study (years)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026