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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04241666
• Other study ID #: 2020-01
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Renal Insufficiency
• Spinal Cord Injuries
• Wounds and Injuries

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