Clinical trial NCT00690586: Fluid Balance, Hormones and Urine Proteomics in Nephrotic Syndrome in Childhood
Official title: Fluid Balance, Hormones and Urine Proteomics in Nephrotic Syndrome in Childhood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrotic Syndrome
Keywords: Nephrotic syndrome
Underfill and overfill theory
Steroid resistance
Urine proteomics
AVP
ANP
Angiotensin II
Renin and Aldosterone
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
name: The Danish Kidney Association
First posted: 2008-06-04
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with nephrotic syndrome will be included from 5 pediatric centrs in Denmark.

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 1,30 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.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Nephrotic syndrome, age below 15 years

Exclusion Criteria:

* Systemic disease e.g. Henoch-Schonleins purpura, Lupus erythematosus, diabetes mellitus
* Age over 15 years
* Treatment with diuretics prior to baseline blood samples

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Pediatrics, Aarhus University Hospital, Skejby
state: Aarhus N
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Søren Rittig, MD
role: STUDY_DIRECTOR
References: