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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Insufficiency; Spinal Cord Injuries
• Intervention / Treatment: Diagnostic test: renal scintigraphy; Diagnostic test: renal doppler sonography

• Study Type: Observational
• Enrollment (Estimated): 51

Contacts and Locations

• Study Contact: Name: Jens Wöllner, Dr.; Phone Number: +41 41 939 59 22; Email: jens.woellner@paraplegie.ch
• Study Contact Backup: Name: Jürgen Pannek, Prof. Dr.; Phone Number: +41 41 939 59 22; Email: juergen.pannek@paraplegie.ch

Study Locations

• Switzerland
  • LU
    • Nottwil, LU, Switzerland, CH-6207
      • Recruiting
      • Swiss Paraplegic Centre
      • Contact: Jens Woellner, MD; Phone Number: +41 41 939 59 41; Email: jens.woellner@paraplegie.ch
      • Sub-Investigator: Jens Woellner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal renal function; individuals with renal clearance >89 ml/min/1.73m²	Diagnostic test: renal scintigraphy; Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys; Diagnostic test: renal doppler sonography; doppler ultrasound of both kidneys
mild renal insufficiency; individuals with renal clearance 60-89 ml/min/1.73m²	Diagnostic test: renal scintigraphy; Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys; Diagnostic test: renal doppler sonography; doppler ultrasound of both kidneys
moderate renal insufficiency; individuals with renal clearance 30-59 ml/min/1.73m²	Diagnostic test: renal scintigraphy; Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys; Diagnostic test: renal doppler sonography; doppler ultrasound of both kidneys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
renal clearance	renal clearance of Technetium-99m-dimercaptosuccinic acid determined by scintigraphy	at the time of inclusion into study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cystatin C concentration	blood serum concentration of Cystatin C (mg/L)	at the time of inclusion into study
Cystatin C clearance	renal clearance of Cystatin C (ml/min) according to the Grubb formula	at the time of inclusion into study
renal peak systolic velocity	Doppler sonography evaluation of renal blood flow during systolic heart phase (m/s)	at the time of inclusion into study
renal peak enddiastolic velocity	Doppler sonography evaluation of renal blood flow during enddiastolic heart phase (m/s)	at the time of inclusion into study
renal resistive index	(systolic velocity - enddiastolic velocity) / systolic velocity	at the time of inclusion into study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
size of kidneys	size of kidneys evaluated by sonography	at the time of inclusion into study
renal tissue echogenicity	renal tissue echogenicity evaluated by sonography	at the time of inclusion into study
bladder evacuation method	method of bladder evacuation	at the time of inclusion into study
lesion level	highest intact spinal cord segment	1 year after spinal cord injury
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
duration of spinal cord injury	time from spinal cord injury to inclusion into study (years)	at the time of inclusion into study
age	time from birth to inclusion into study (years)	at the time of inclusion into study

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil
• Collaborators: Lotte und Adolf Hotz-Sprenger Stiftung
• Investigators: Principal Investigator: Jens Wöllner, Dr., Swiss Paraplegic Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Kidney Diseases; Urologic Diseases; Trauma, Nervous System; Spinal Cord Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Renal Insufficiency; Spinal Cord Injuries
• Other Study ID Numbers: 2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data will be made available upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No