Spinal Cord InjuriesNCT04241666
Sonographic Examination of Renal Function in Individuals With Long-term Spinal Cord Injury
An observational study of Spinal Cord Injuries and Renal Insufficiency, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Spinal Cord Injuries, Renal Insufficiency
- What is being tested?
- renal scintigraphy and renal doppler sonography
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jan 2022to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: individuals with long-term lower urinary tract dysfunction due to spinal cord injury
Who may be able to join
- long-term spinal cord injury (≥10 years)
- age ≥30 years
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, CH-6207
About this study
Official title: Comparison of Sonographic Examination of Renal Function With Gold-standard Examination in Individuals With Long-term Spinal Cord Injury
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.
- Conditions
- Spinal Cord Injuries, Renal Insufficiency
- Being tested
- renal scintigraphy, renal doppler sonography
- Medical subject headings
- Spinal Cord Injuries, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal scintigraphyDiagnostic test
Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys
renal doppler sonographyDiagnostic test
doppler ultrasound of both kidneys
| Study group | Role | What they receive |
|---|---|---|
| normal renal function | individuals with renal clearance >89 ml/min/1.73m² Receives: Diagnostic Test: renal scintigraphy; Diagnostic Test: renal doppler sonography | |
| mild renal insufficiency | individuals with renal clearance 60-89 ml/min/1.73m² Receives: Diagnostic Test: renal scintigraphy; Diagnostic Test: renal doppler sonography | |
| moderate renal insufficiency | individuals with renal clearance 30-59 ml/min/1.73m² Receives: Diagnostic Test: renal scintigraphy; Diagnostic Test: renal doppler sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal clearance
renal clearance of Technetium-99m-dimercaptosuccinic acid determined by scintigraphy
Measured: at the time of inclusion into study
Secondary outcomes (5)
Cystatin C concentration
blood serum concentration of Cystatin C (mg/L)
Measured: at the time of inclusion into study
Cystatin C clearance
renal clearance of Cystatin C (ml/min) according to the Grubb formula
Measured: at the time of inclusion into study
renal peak systolic velocity
Doppler sonography evaluation of renal blood flow during systolic heart phase (m/s)
Measured: at the time of inclusion into study
renal peak enddiastolic velocity
Doppler sonography evaluation of renal blood flow during enddiastolic heart phase (m/s)
Measured: at the time of inclusion into study
renal resistive index
(systolic velocity - enddiastolic velocity) / systolic velocity
Measured: at the time of inclusion into study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start5 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Collaborators
- Lotte und Adolf Hotz-Sprenger Stiftung
- Responsible party
- Sponsor
- Investigators
- Jens Wöllner, Dr., Principal investigator, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241666
- Sponsor's protocol ID
- 2020-01
- Status last verified
- Feb 2025
- First submitted
- 22 Jan 2020
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be made available upon reasonable request
Publications
Jehli E, Krebs J, Schirp U, Walter MA, Wollner J, Pannek J. Decoding kidney function: evaluating arterial resistive index and cystatin C serum values in individuals with spinal cord injury. World J Urol. 2025 Dec 15;44(1):43. doi: 10.1007/s00345-025-06135-w.
PubMed 41396487
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sonographic Examination of Renal Function With Gold-standard Examination in Individuals With Long-term Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04241666
- Acronym / sponsor ID
- 2020-01
- Conditions
- Spinal Cord Injuries, Renal Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Collaborators
- Lotte und Adolf Hotz-Sprenger Stiftung
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal renal function | – | Diagnostic Test: renal scintigraphy, Diagnostic Test: renal doppler sonographyindividuals with renal clearance >89 ml/min/1.73m² |
| mild renal insufficiency | – | Diagnostic Test: renal scintigraphy, Diagnostic Test: renal doppler sonographyindividuals with renal clearance 60-89 ml/min/1.73m² |
| moderate renal insufficiency | – | Diagnostic Test: renal scintigraphy, Diagnostic Test: renal doppler sonographyindividuals with renal clearance 30-59 ml/min/1.73m² |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with long-term lower urinary tract dysfunction due to spinal cord injury
Key inclusion criteria (3 listed)
- long-term spinal cord injury (≥10 years)
- age ≥30 years
- written informed consent
Key exclusion criteria (6 listed)
- dementia or severe intellectual impairment
- serious internal illness
- previous or current tumor disease
- known allergy to the radioactive marker (Technetium)
- pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal scintigraphyTechnetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys | Diagnostic test | mild renal insufficiency, moderate renal insufficiency, normal renal function |
| renal doppler sonographydoppler ultrasound of both kidneys | Diagnostic test | mild renal insufficiency, moderate renal insufficiency, normal renal function |
Primary outcome
renal clearance
Time frame: at the time of inclusion into study
renal clearance of Technetium-99m-dimercaptosuccinic acid determined by scintigraphy
5 secondary outcomes
Cystatin C concentration
Time frame: at the time of inclusion into study
Cystatin C clearance
Time frame: at the time of inclusion into study
renal peak systolic velocity
Time frame: at the time of inclusion into study
renal peak enddiastolic velocity
Time frame: at the time of inclusion into study
renal resistive index
Time frame: at the time of inclusion into study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 41396487Jehli E, Krebs J, Schirp U, Walter MA, Wollner J, Pannek J. Decoding kidney function: evaluating arterial resistive index and cystatin C serum values in individuals with spinal cord injury. World J Urol. 2025 Dec 15;44(1):43. doi: 10.1007/s00345-025-06135-w.
- Individual participant dataSharing planned: No. data will be made available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Wöllner, Dr. principal investigator
Swiss Paraplegic Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Renal Insufficiency, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal clearance (time frame: at the time of inclusion into study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04241666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.