An observational study in Hemolytic-Uremic Syndrome, Children and Parents, sponsored by University Children's Hospital, Zurich. Completed at 1 site in Switzerland. Open to participants aged 2 Months to 17 Years. Per ClinicalTrials.gov, last updated 2013-09-04.
Sponsored by University Children's Hospital, Zurich · Observational
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The purpose of this study is to investigate the clinical, cognitive outcome and psychosocial outcome of haemolytic uraemic syndrome in childhood.
The haemolytic uraemic syndrome (HUS) is the leading cause of acute renal failure in childhood. The more common typical HUS is mostly caused by Shigatoxin-producing enterohaemorrhagic Escherichia coli (EHEC). The rarer atypical HUS is mainly caused by different genetic abnormalities in complement regulatory proteins.
About 50 till 60 percent of all patients with HUS develop a severe acute renal failure and require dialysis. Resulting from new diagnostic and therapeutic approaches the survival rate increased during the last years. Despite this, there are only few data concerning long-term prognosis, cognitive and motoric development, as well as psychological coping and health-related quality of life of affected children and their parents.
The main purposes of this study are: the evaluation of the long-term renal function of pediatric HUS-patients; the evaluation of the dialysis method in the acute phase of the disease and its impact on the duration of the renal-placement-therapy, as well as the long-term renal function; the evaluation of the intellectual and motoric performance of affected children and the evaluation of the health-related quality of life and psychological processing of the patients themselves and their parents.
All cases of HUS treated at the University Children's Hospital Zurich between 1995 and 2012 will be analyzed retrospectively. In the course of a routine-follow-up-examination the clinical data of patients up to the age of 17 years will be actualized and completed. The results of clinical and paraclinical investigations related to renal function will be evaluated to describe the clinical features of haemolytic uraemic syndrome in childhood.
Intellectual performance will be analyzed with the Wechsler-Intelligence Scale for Children-IV (WISC-IV) and motoric performance with the Zurich Neuromotor Assessment in children at the age from 6 to 16 years.
The health-related quality-of-life of all parents and affected children from the age of 7 years will be assessed by different generic quality-of-life-instruments.
28 studies on the registry are indexed under Hemolytic-Uremic Syndrome; 7 are open to participants now.
This study's enrollment of 89 is above the median of 50 across 13 observational studies indexed under Hemolytic-Uremic Syndrome.
Browse Hemolytic-Uremic Syndrome studies →University Children's Hospital, Zurich is the lead sponsor of 95 studies on the registry; 23 are open to participants now.
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children and youth from 2 months to 17 years in who had suffered from haemolytic uraemic syndrome
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
- renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood
Time frame: 1 year 5 months
- quality of life of children with haemolytic uraemic syndrome and their parents
Time frame: 1 year 5 months
- neuropsychological sequelae of children with haemolytic uraemic syndrome
Time frame: 1 year 5 months
The record gives a start of Feb 2012, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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University Children's Hospital, Zurich