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OpenTrials
Completed

NCT Number: NCT06565351

S-cystatin C vs.Injection Clearance Measurements to Estimate Kidney Function in Patients With Spinal Cord Injuries

* In individuals with spinal cord injury (SCI) kidney function defined as Glomerular Filtration Rate (GFR) is monitored by injection of e.g.99mDTPA and subsequent blood sampling (DTPA-clearance) * GFR calculated from plasma samples of the endogenous substance s-Cystatin C (eGFR cystatin C) was compared to DTPA-clearance in 248 individuals with SCI. * It is concluded that eGFR based on plasma s-cystatin C can replace the more tedious 99mDTPA-clearance procedures in individuals with SCI

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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 Failure Renal Insufficiency Spinal Cord Diseases Trauma, Nervous System Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital, Rigshospitalet; Glostrup

Glostrup Municipality, DK-2600, Denmark

Who can participate

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

Inclusion criteria

Neurogenic bladder dysfunction due to spinal cord injury

Exclusion criteria

None

Treatment and study plan

eGFR estimated from creatinine and cystatin C

Other

eGFR estimated from creatinine and cystatin C was compared to GFR measured by 99mTc-DTPA clearance (gold standard)

Primary outcomes

  1. Estimated clearance of Cystatin C (eGFR cystatin C)

    Time frame: through study period (2 years)

    The estimated clearance of cystatin (eGFR) C is calculated from s-cystatin C and the age and height and weight of the individual. It is corrected for Body Surface area. In this study it is compared to the Gold Standard examination DTPA-clearance

Secondary outcomes

  1. Test/ retest variability of eGFR cystatin C

    Time frame: Up to three months

    Blood samples for determination of Cystatin C is taken twice within maximally three months, to determine the repeatability of eGFR cystatin C

  2. Long term repeatability of eGFR cystatin C

    Time frame: Up to three years

    Blood samples for determination of cystatin C is taken twice with an interval of two-three years to determine long term repeatability. This is compared to simultaneously acquired measurements of DTPA-clearance

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Feasibility of Replacing 99mTc-DTPA GFR Measurements With eGFR From s-Cystatin C in Individuals With Spinal Cord Injuries

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

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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