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

NCT04241666 | Completed

• 1 other identifier: 2020-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• renal clearance

  renal clearance of Technetium-99m-dimercaptosuccinic acid determined by scintigraphy

  at the time of inclusion into study

Secondary Outcomes (5)

• Cystatin C concentration

  at the time of inclusion into study

• Cystatin C clearance

  at the time of inclusion into study

• renal peak systolic velocity

  at the time of inclusion into study

• renal peak enddiastolic velocity

  at the time of inclusion into study

• renal resistive index

  at the time of inclusion into study

Other Outcomes (7)

• size of kidneys

  at the time of inclusion into study

• renal tissue echogenicity

  at the time of inclusion into study

• bladder evacuation method

  at the time of inclusion into study

Study Arms (3)

normal renal function

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

Diagnostic Test: renal scintigraphy; Diagnostic Test: renal doppler sonography

mild renal insufficiency

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

Diagnostic Test: renal scintigraphy; Diagnostic Test: renal doppler sonography

moderate renal insufficiency

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

Diagnostic Test: renal scintigraphy; Diagnostic Test: renal doppler sonography

Interventions

renal scintigraphy DIAGNOSTIC_TEST

Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys

mild renal insufficiency; moderate renal insufficiency; normal renal function

renal doppler sonography DIAGNOSTIC_TEST

doppler ultrasound of both kidneys

mild renal insufficiency; moderate renal insufficiency; normal renal function

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

individuals with long-term lower urinary tract dysfunction due to spinal cord injury

You may qualify if:

• long-term spinal cord injury (≥10 years)
• age ≥30 years
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead
• Lotte und Adolf Hotz-Sprenger Stiftung: collaborator

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, CH-6207, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 41396487 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Renal Insufficiency

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jens Wöllner, Dr.

  Swiss Paraplegic Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: January 5, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)