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

Completed

• Conditions: Spinal Cord Injuries; Renal Failure
• Interventions: Other: eGFR estimated from creatinine and cystatin C

• Registration Number: NCT06565351
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

* 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

Neurogenic bladder dysfunction due to spinal cord injury

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spinal Cord Injury Individuals	eGFR estimated from creatinine and cystatin C	248 individuals with spinal cord injury and neurogenic bladder dysfunction, coming to routine controls of the renal function. Glomerular filtration rate (GFR) was measured by 99mTc-DTPA clearance and estimated by eGFR from creatinine and Cystatine C

Primary Outcome Measures

Name	Time	Method
Estimated clearance of Cystatin C (eGFR cystatin C)	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 Outcome Measures

Name	Time	Method
Test/ retest variability of eGFR cystatin C	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
Long term repeatability of eGFR cystatin C	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

Trial Locations

Locations (1)

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