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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666548
• Other study ID #: KEK-ZH-Nr. 2011-0394
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: September 3, 2013
• Start date: February 2012
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 17 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Azotemia
• Children
• Hemolytic-Uremic Syndrome
• Parents
• Psychological Adjustment
• Syndrome

Locations

Country	Name	City	State
Switzerland	Nephrology Unit of the University Children`s Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

Brunner K, Bianchetti MG, Neuhaus TJ. Recovery of renal function after long-term dialysis in hemolytic uremic syndrome. Pediatr Nephrol. 2004 Feb;19(2):229-31. Epub 2003 Nov 27. — View Citation

Falger J, Landolt MA, Latal B, Rüth EM, Neuhaus TJ, Laube GF. Outcome after renal transplantation. Part II: quality of life and psychosocial adjustment. Pediatr Nephrol. 2008 Aug;23(8):1347-54. doi: 10.1007/s00467-008-0798-x. Epub 2008 Apr 3. — View Citation

Falger J, Latal B, Landolt MA, Lehmann P, Neuhaus TJ, Laube GF. Outcome after renal transplantation. Part I: intellectual and motor performance. Pediatr Nephrol. 2008 Aug;23(8):1339-45. doi: 10.1007/s00467-008-0795-0. Epub 2008 Apr 4. — View Citation

Neuhaus TJ, Calonder S, Leumann EP. Heterogeneity of atypical haemolytic uraemic syndromes. Arch Dis Child. 1997 Jun;76(6):518-21. Review. — View Citation

Pollock KG, Duncan E, Cowden JM. Emotional and behavioral changes in parents of children affected by hemolytic-uremic syndrome associated with verocytotoxin-producing Escherichia coli: a qualitative analysis. Psychosomatics. 2009 May-Jun;50(3):263-9. doi: 10.1176/appi.psy.50.3.263. — View Citation

Rüth EM, Landolt MA, Neuhaus TJ, Kemper MJ. Health-related quality of life and psychosocial adjustment in steroid-sensitive nephrotic syndrome. J Pediatr. 2004 Dec;145(6):778-83. — View Citation

Schifferli A, von Vigier RO, Fontana M, Spartà G, Schmid H, Bianchetti MG, Rudin C; Swiss Pediatric Surveillance Unit. Hemolytic-uremic syndrome in Switzerland: a nationwide surveillance 1997-2003. Eur J Pediatr. 2010 May;169(5):591-8. doi: 10.1007/s00431-009-1079-9. Epub 2009 Oct 15. — View Citation

Schlieper A, Orrbine E, Wells GA, Clulow M, McLaine PN, Rowe PC. Neuropsychological sequelae of haemolytic uraemic syndrome. Investigators of the HUS Cognitive Study. Arch Dis Child. 1999 Mar;80(3):214-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood		1 year 5 months	No
Primary	- quality of life of children with haemolytic uraemic syndrome and their parents		1 year 5 months	No
Primary	- neuropsychological sequelae of children with haemolytic uraemic syndrome		1 year 5 months	No