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Completed

NCT Number: NCT04241666

Sonographic Examination of Renal Function 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.

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, CH-6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

renal scintigraphy

Diagnostic Test

Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys

renal doppler sonography

Diagnostic Test

doppler ultrasound of both kidneys

Primary outcomes

  1. renal clearance

    Time frame: at the time of inclusion into study

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

Secondary outcomes

  1. Cystatin C concentration

    Time frame: at the time of inclusion into study

    blood serum concentration of Cystatin C (mg/L)

  2. Cystatin C clearance

    Time frame: at the time of inclusion into study

    renal clearance of Cystatin C (ml/min) according to the Grubb formula

  3. renal peak systolic velocity

    Time frame: at the time of inclusion into study

    Doppler sonography evaluation of renal blood flow during systolic heart phase (m/s)

  4. renal peak enddiastolic velocity

    Time frame: at the time of inclusion into study

    Doppler sonography evaluation of renal blood flow during enddiastolic heart phase (m/s)

  5. renal resistive index

    Time frame: at the time of inclusion into study

    (systolic velocity - enddiastolic velocity) / systolic velocity

Other outcomes

  1. size of kidneys

    Time frame: at the time of inclusion into study

    size of kidneys evaluated by sonography

  2. renal tissue echogenicity

    Time frame: at the time of inclusion into study

    renal tissue echogenicity evaluated by sonography

  3. bladder evacuation method

    Time frame: at the time of inclusion into study

    method of bladder evacuation

  4. lesion level

    Time frame: 1 year after spinal cord injury

    highest intact spinal cord segment

  5. lesion severity

    Time frame: 1 year after spinal cord injury

    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)

  6. duration of spinal cord injury

    Time frame: at the time of inclusion into study

    time from spinal cord injury to inclusion into study (years)

  7. age

    Time frame: at the time of inclusion into study

    time from birth to inclusion into study (years)

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Collaborators

  • Lotte und Adolf Hotz-Sprenger Stiftung

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 27, 2020
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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