Ignite Creation Date:
2024-05-05 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00690586
Status:
COMPLETED
Last Update Posted:
2010-06-08
First Post:
2008-06-02
Brief Title:
Fluid Balance Hormones and Urine Proteomics in Nephrotic Syndrome in Childhood
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
Fluid Balance Hormones and Urine Proteomics in Nephrotic Syndrome in Childhood
Status:
COMPLETED
Status Verified Date:
2008-06
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 describe the hormones controlling fluid balance in pediatric patients with nephrotic syndrome Further more an analysis of the urinary and plasma proteins will be done using proteomics Different composition of proteins in the urine or plasma might indicate if the patients will respond to treatment or not
Detailed Description:
Nephrotic syndrome represents the association of proteinuria hypoalbuminemia oedema and hyperlipidemia The pathogenesis of the oedemas remains controversial The underfill theory is the traditional explanation where massive proteinuria leads to low plasma albumine and a subsequent decrease in intravascular osmotic pressure leading to edema formations Because most patients are normotensive and have normal intravascular pressure the overfill theory has been proposed suggesting a primary defect in renal sodium handling being responsible for oedema formation
Ten percent of the children with nephrotic syndrome do not respond to standard steroid treatment and a significant proportion of these patients progress towards end-stage renal failure At initial presentation it cannot be said if a patient will respond to treatment or not
The purposes of the sudy
1 To describe changes in the hormones Aldosterone Atrial Natriuretic Peptide ANP Arginin Vasopressin AVP Renin and Angiotensin II in patients with idiopathic nephrotic syndrome and to analyse to what extend the change in these hormones reflected a underfill or overfill situation
2 To describe changes in the urine concentration of the water channel AQP II and the sodium channel ENaC during the course of nephrotic syndrome
3 To test the hypothesis that urine and plasma proteomics from patients with steroid resistant nephrotic syndrome differs from patients with steroid sensitive nephrotic syndrome
50 pediatric patients with nephrotic syndrome will be included after informed consent from both parents
At day 1 2 3 30 and 120 blood samples for hormones will be taken together with creatinin albumine Na K Hgb An Echocardiography will be performed at day 1 and day 30 to determine v cava inferior index
At day 130 and 120 urine and plasma will be collected for proteomics and measurement of AQP II and ENaC concentrations
Further more a clinical examination will be performed at day 1 2 3 30 and 120 and weight blood pressure and response to treatment will be recorded
Ten percent of the children with nephrotic syndrome do not respond to standard steroid treatment and a significant proportion of these patients progress towards end-stage renal failure At initial presentation it cannot be said if a patient will respond to treatment or not
The purposes of the sudy
1 To describe changes in the hormones Aldosterone Atrial Natriuretic Peptide ANP Arginin Vasopressin AVP Renin and Angiotensin II in patients with idiopathic nephrotic syndrome and to analyse to what extend the change in these hormones reflected a underfill or overfill situation
2 To describe changes in the urine concentration of the water channel AQP II and the sodium channel ENaC during the course of nephrotic syndrome
3 To test the hypothesis that urine and plasma proteomics from patients with steroid resistant nephrotic syndrome differs from patients with steroid sensitive nephrotic syndrome
50 pediatric patients with nephrotic syndrome will be included after informed consent from both parents
At day 1 2 3 30 and 120 blood samples for hormones will be taken together with creatinin albumine Na K Hgb An Echocardiography will be performed at day 1 and day 30 to determine v cava inferior index
At day 130 and 120 urine and plasma will be collected for proteomics and measurement of AQP II and ENaC concentrations
Further more a clinical examination will be performed at day 1 2 3 30 and 120 and weight blood pressure and response to treatment will be recorded
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