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van CCT (UK)

van CCT (UK)

Wat is de rol van stress in het veroorzaken van eiwitverlies in de urine bij kinderen met het nefrotisch syndroom?

- candidate number14302
- NTR NumberNTR3829
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jan-2013
- Secondary IDsNL41194.018.12 CCMO
- Public TitleWat is de rol van stress in het veroorzaken van eiwitverlies in de urine bij kinderen met het nefrotisch syndroom?
- Scientific TitleThe role of psychological stress in the occurrence of relapses in childhood steroid sensitive idiopathic nephrotic syndrome.
- hypothesisResearch question 1:
Is the occurrence of relapses related to an increased level of perceived stress?

Research question 2:
Is the occurrence of relapses related to individual and/or familial reactions to stressful life events?

Research question 3:
Is the occurrence of relapses related to individual and/or familial reactions to stressful life events?

Research question 4:
Can salivary secretion patterns of cortisol and amylase be correlated with the occurrence of relapses in stressful situations?
- Healt Condition(s) or Problem(s) studiedIdiopathic nephrotic syndrome, Stress
- Inclusion criteria1. Children from 5 to 12 years of age at the time of inclusion;
2. Patient is classified as steroid sensitive;
3. Patient known to present with at least one relapse / year or patients with a first presentation of the idiopathic nephrotic syndrome. Relapse definition: dipstick protein ++ on 3 consecutive days.
- Exclusion criteria1. Non idiopathic nephrotic syndrome;
2. No remission after 4 weeks prednison 60 mg/m2/day;
3. Children younger than 5 or older than 12 years.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2012
- planned closingdate1-dec-2014
- Target number of participants40
- InterventionsComputer based questionnares.
- Primary outcomeRelapse nephrotic syndrome.
- Secondary outcome N/A
- Timepoints1-12-2012 Inclusion;
1-12-2013 End of inclusion;
1-12-2014 End of follow-up.
- Trial web
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Emma Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Dutch Kidney Foundation (Nierstichting Nederland)
- PublicationsN/A
- Brief summaryIdiopathic Nephrotic Syndrome is the most frequent glomerular disease in children. Ten percent of patients are steroid resistant and have a high risk to develop end stage renal failure. In the group of steroid sensitive patients about 50 percent will have frequent relapses leading to the prolonged use of high prednisone dosage or to steroid sparing agents such as cyclophosphamide or cyclosporine.

Recently Takahashi and co-workers (2007) have shown that after common cold, the events preceding relapses most frequently were stressful situations. This observation could support the hypothesis of somatic consequences of mental events in idiopathic nephrotic syndrome just as already described in several other immunologically mediated diseases such as SLE, skin diseases, asthma, and inflammatory bowel diseases (Picardi and Abeni, 2001; Mawdsley and Rampton, 2005; Straub et al, 2005; Bricou et al, 2006; Chen and Miller, 2007). Recent progresses in neuroendocrine-immunology give a scientific support to the relation between psychological distress and somatic illness (for a review: Mawdsley and Rampton, 2005).

Parents of children with ISSNS often report the concomitant relation between stress events (inducing excitation or fears) and relapses. They have expressed their frustration towards the lack of attention paid by doctors to their observation. Furthermore, they have asked us to help them in setting up a registry for parents and patients. This has given us the idea to use this registry to the purpose of evaluating in a prospective study what is the role of stress as trigger for relapses.

Each parent / patient will be able to access an electronic diary to register the daily use of medications and the occurrence of stressful events e.g. start of school, school examination, anniversary, visit to the dentist or the pediatrician, death of a relative. In addition proteinuria will be measured daily using Albustix. Using statistical analysis we will investigate if there is a temporal concentration of relapses of disease around stressful events.

In case this pilot study will demonstrate a temporal relation between stress events and relapses, further investigations (using questionnaire on child vulnerability, overprotection and parental stress) will be set up to study psychological features of the patient and his family in order to define criteria allowing to trace patients with high sensibility to stress. This will allow preventive training for coping with stress of patients and their families who need it. Finally, the confirmation of the triggering effect of stress on relapses should open new fields for fundamental investigations on the pathophysiological process responsible for ISSNS and on neuroendocrine-immunological interactions.
- Main changes (audit trail)
- RECORD31-jan-2013 - 9-feb-2013

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