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

NCT ID: NCT04241666

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-05

Study Completion Date

2025-01-31

Brief Summary

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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

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Conditions

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Spinal Cord Injuries Renal Insufficiency

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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normal renal function

individuals with renal clearance \>89 ml/min/1.73m²

renal scintigraphy

Intervention Type DIAGNOSTIC_TEST

Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys

renal doppler sonography

Intervention Type DIAGNOSTIC_TEST

doppler ultrasound of both kidneys

mild renal insufficiency

individuals with renal clearance 60-89 ml/min/1.73m²

renal scintigraphy

Intervention Type DIAGNOSTIC_TEST

Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys

renal doppler sonography

Intervention Type DIAGNOSTIC_TEST

doppler ultrasound of both kidneys

moderate renal insufficiency

individuals with renal clearance 30-59 ml/min/1.73m²

renal scintigraphy

Intervention Type DIAGNOSTIC_TEST

Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys

renal doppler sonography

Intervention Type DIAGNOSTIC_TEST

doppler ultrasound of both kidneys

Interventions

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renal scintigraphy

Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys

Intervention Type DIAGNOSTIC_TEST

renal doppler sonography

doppler ultrasound of both kidneys

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lotte und Adolf Hotz-Sprenger Stiftung

UNKNOWN

Sponsor Role collaborator

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Wöllner, Dr.

Role: PRINCIPAL_INVESTIGATOR

Swiss Paraplegic Centre

Locations

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Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2020-01

Identifier Type: -

Identifier Source: org_study_id

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