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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01666548
First received: July 31, 2012
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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
Hemolytic-Uremic Syndrome
Children
Parents
Psychological Adjustment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects

Resource links provided by NLM:


Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • - renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood [ Time Frame: 1 year 5 months ] [ Designated as safety issue: No ]
  • - quality of life of children with haemolytic uraemic syndrome and their parents [ Time Frame: 1 year 5 months ] [ Designated as safety issue: No ]
  • - neuropsychological sequelae of children with haemolytic uraemic syndrome [ Time Frame: 1 year 5 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

urine, native-blood, blood plasma, EDTA stabilized blood, heparin blood


Enrollment: 89
Study Start Date: February 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   2 Months to 17 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666548

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

Additional Information:
Publications:

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01666548     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2011-0394
Study First Received: July 31, 2012
Last Updated: September 3, 2013
Health Authority: Switzerland: Swissmedic

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
Azotemia
Hemolysis
Uremia
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014