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Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects

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ClinicalTrials.gov Identifier: NCT01666548
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : September 4, 2013
Information provided by (Responsible Party):
University Children's Hospital, Zurich

Brief Summary:

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.

Condition or disease
Hemolytic-Uremic Syndrome Children Parents Psychological Adjustment

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects
Study Start Date : February 2012
Primary Completion Date : August 2013
Study Completion Date : August 2013

Primary Outcome Measures :
  1. - renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood [ Time Frame: 1 year 5 months ]
  2. - quality of life of children with haemolytic uraemic syndrome and their parents [ Time Frame: 1 year 5 months ]
  3. - neuropsychological sequelae of children with haemolytic uraemic syndrome [ Time Frame: 1 year 5 months ]

Biospecimen Retention:   Samples Without DNA
urine, native-blood, blood plasma, EDTA stabilized blood, heparin blood

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
children and youth from 2 months to 17 years in who had suffered from haemolytic uraemic syndrome

Inclusion Criteria:

  • children and youth from 2 months to 17 years who had suffered from haemolytic uraemic syndrome
  • willingness and ability to participate in the study
  • freely signed informed consent

Exclusion Criteria:

  • missing written informed consent
  • children who do not fulfil the age criterion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666548

Nephrology Unit of the University Children`s Hospital Zurich
Zurich, Switzerland, CH-8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Principal Investigator: Giuseppina Spartà, MD Nephrology Unit, University Children`s Hospital, Zurich, Steinwiesstrasse 75, CH-8032 Zürich, Switzerland


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01666548     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2011-0394
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013

Keywords provided by University Children's Hospital, Zurich:
haemolytic uraemic syndrome
complications of HUS
renal replacement treatment
renal function outcome
neuropsychological sequelae
psychological adjustment
quality of life

Additional relevant MeSH terms:
Hemolytic-Uremic Syndrome
Pathologic Processes
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Hematologic Diseases
Thrombotic Microangiopathies
Blood Platelet Disorders