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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04241666
Other study ID # 2020-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 5, 2022
Est. completion date February 2025

Study information

Verified date February 2024
Source Swiss Paraplegic Research, Nottwil
Contact Jens Wöllner, Dr.
Phone +41 41 939 59 22
Email jens.woellner@paraplegie.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 51
Est. completion date February 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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


Intervention

Diagnostic Test:
renal scintigraphy
Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys
renal doppler sonography
doppler ultrasound of both kidneys

Locations

Country Name City State
Switzerland Swiss Paraplegic Centre Nottwil LU

Sponsors (2)

Lead Sponsor Collaborator
Swiss Paraplegic Research, Nottwil Lotte und Adolf Hotz-Sprenger Stiftung

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other size of kidneys size of kidneys evaluated by sonography at the time of inclusion into study
Other renal tissue echogenicity renal tissue echogenicity evaluated by sonography at the time of inclusion into study
Other bladder evacuation method method of bladder evacuation at the time of inclusion into study
Other lesion level highest intact spinal cord segment 1 year after spinal cord injury
Other lesion severity severity 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) 1 year after spinal cord injury
Other duration of spinal cord injury time from spinal cord injury to inclusion into study (years) at the time of inclusion into study
Other age time from birth to inclusion into study (years) at the time of inclusion into study
Primary renal clearance renal clearance of Technetium-99m-dimercaptosuccinic acid determined by scintigraphy at the time of inclusion into study
Secondary Cystatin C concentration blood serum concentration of Cystatin C (mg/L) at the time of inclusion into study
Secondary Cystatin C clearance renal clearance of Cystatin C (ml/min) according to the Grubb formula at the time of inclusion into study
Secondary renal peak systolic velocity Doppler sonography evaluation of renal blood flow during systolic heart phase (m/s) at the time of inclusion into study
Secondary renal peak enddiastolic velocity Doppler sonography evaluation of renal blood flow during enddiastolic heart phase (m/s) at the time of inclusion into study
Secondary renal resistive index (systolic velocity - enddiastolic velocity) / systolic velocity at the time of inclusion into study
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