Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300066
Status:
COMPLETED
Last Update Posted:
2010-05-28
First Post:
2006-03-06
Brief Title:
Assessment of Serum Cystatin C as a Marker of Kidney Function in Children
Sponsor:
Aalborg University Hospital
Organization:
Aalborg University Hospital
Study Overview
Official Title:
Prediction Equations for Glomerular Filtration Rate in Children Based on Serum Cystatin C and Body Cell Mass
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess serum cystatin C as a marker of kidney function glomerular filtration rate GFR in children aged 2-14 The individual production rate and possible extra renal elimination of cystatin C based on body composition data is included to develop new algorithms to estimate GFR
Furthermore day-to-day variation on serum cystatin C is investigated
Furthermore day-to-day variation on serum cystatin C is investigated
Detailed Description:
Today childrens kidney function glomerular filtration rate GFR can be monitored by two methods
1 indirectly by serum creatinine or
2 directly by injection of a radioactive substance followed by several blood samples
The first method is inaccurate with many drawbacks whereas the latter is precise but time-consuming and unpleasant for the child Therefore there is a need for a new method for investigating GFR in children
Serum cystatin C is a small protein that is produced with a constant rate in all nucleated cells in the body It meets many of the characteristics of an ideal marker of GFR because of the way it is excreted in the kidneys However earlier studies have not proven serum cystatin C to be convincingly better than serum creatinine Why If there is considerable extra renal elimination serum cystatin C alone isnt enough to estimate GFR Therefore the individual production rate and possible extra renal elimination of cystatin C are included in this study To assess these factors the children are submitted to bioelectrical impedance spectroscopy BIS to estimate their body composition including body cell mass as cystatin C is produced in all nucleated cells To validate the BIS data dual energy x-ray absorptiometry DEXA will be conducted on 100 of the included children
Based on serum cystatin C and the individual age-corrected extra renal elimination rate of cystatin C new algorithms to calculate GFR can be developed
Furthermore day-to-day variation in serum cystatin C and BIS data which is expected to be low is investigated in 100 of the included children
Hypotheses
1 Day-to-day variation on serum cystatin C is low
2 Serum cystatin C raises parallel to falling GFR with time which means that serum cystatin C can be used to monitor changes in kidney function in each patient
3 Based on body composition regression analysis and serum cystatin C values GFR can be estimated in children aged 2-14
4 GFR calculated as stated above is a more precise measurement of kidney function and changes in kidney function than GFR estimated from serum creatinine
5 Data of body composition estimated by BIS do not deviate from data estimated by DEXA
6 Day-to-day variation in data for body composition measured by BIS is low
The project includes 200 children aged 2-14 who are referred for routine examination of GFR in two Departments of Nuclear Medicine
1 indirectly by serum creatinine or
2 directly by injection of a radioactive substance followed by several blood samples
The first method is inaccurate with many drawbacks whereas the latter is precise but time-consuming and unpleasant for the child Therefore there is a need for a new method for investigating GFR in children
Serum cystatin C is a small protein that is produced with a constant rate in all nucleated cells in the body It meets many of the characteristics of an ideal marker of GFR because of the way it is excreted in the kidneys However earlier studies have not proven serum cystatin C to be convincingly better than serum creatinine Why If there is considerable extra renal elimination serum cystatin C alone isnt enough to estimate GFR Therefore the individual production rate and possible extra renal elimination of cystatin C are included in this study To assess these factors the children are submitted to bioelectrical impedance spectroscopy BIS to estimate their body composition including body cell mass as cystatin C is produced in all nucleated cells To validate the BIS data dual energy x-ray absorptiometry DEXA will be conducted on 100 of the included children
Based on serum cystatin C and the individual age-corrected extra renal elimination rate of cystatin C new algorithms to calculate GFR can be developed
Furthermore day-to-day variation in serum cystatin C and BIS data which is expected to be low is investigated in 100 of the included children
Hypotheses
1 Day-to-day variation on serum cystatin C is low
2 Serum cystatin C raises parallel to falling GFR with time which means that serum cystatin C can be used to monitor changes in kidney function in each patient
3 Based on body composition regression analysis and serum cystatin C values GFR can be estimated in children aged 2-14
4 GFR calculated as stated above is a more precise measurement of kidney function and changes in kidney function than GFR estimated from serum creatinine
5 Data of body composition estimated by BIS do not deviate from data estimated by DEXA
6 Day-to-day variation in data for body composition measured by BIS is low
The project includes 200 children aged 2-14 who are referred for routine examination of GFR in two Departments of Nuclear Medicine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None