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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241666
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : September 29, 2022
Sponsor:
Collaborators:
Lotte und Adolf Hotz-Sprenger Stiftung
Swiss Paraplegic Research
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

Study Description
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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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Renal Insufficiency Diagnostic Test: renal scintigraphy Diagnostic Test: renal doppler sonography

Study Design
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Study Type : Observational
Estimated Enrollment : 51 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Comparison of Sonographic Examination of Renal Function With Gold-standard Examination in Individuals With Long-term Spinal Cord Injury
Actual Study Start Date : September 13, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. renal clearance [ Time Frame: at the time of inclusion into study ]
    renal clearance of Technetium-99m-dimercaptosuccinic acid determined by scintigraphy


Secondary Outcome Measures :
  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 Outcome Measures:
  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)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
individuals with long-term lower urinary tract dysfunction due to spinal cord injury
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241666


Contacts
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Contact: Jens Wöllner, Dr. +41 41 939 59 22 jens.woellner@paraplegie.ch
Contact: Jürgen Pannek, Prof. Dr. +41 41 939 59 22 juergen.pannek@paraplegie.ch

Locations
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Switzerland
Swiss Paraplegic Centre Recruiting
Nottwil, LU, Switzerland, CH-6207
Contact: Jens Woellner, MD    +41 41 939 59 41    jens.woellner@paraplegie.ch   
Sub-Investigator: Jens Woellner, MD         
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Lotte und Adolf Hotz-Sprenger Stiftung
Swiss Paraplegic Research
Investigators
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Principal Investigator: Jens Wöllner, Dr. Swiss Paraplegic Centre
More Information
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Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT04241666    
Other Study ID Numbers: 2020-01
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: data will be made available upon reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Renal Insufficiency
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
 Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases