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

NCT01666548 | Completed

• 1 other identifier: KEK-ZH-Nr. 2011-0394
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemolytic-Uremic Syndrome; Children; Parents; Psychological Adjustment

Keywords

haemolytic uraemic syndrome; complications of HUS; renal replacement treatment; renal function outcome; neuropsychological sequelae; psychological adjustment; quality of life

Outcome Measures

Primary Outcomes (3)

• - renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood

  1 year 5 months

• - quality of life of children with haemolytic uraemic syndrome and their parents

  1 year 5 months

• - neuropsychological sequelae of children with haemolytic uraemic syndrome

  1 year 5 months

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

children and youth from 2 months to 17 years in who had suffered from haemolytic uraemic syndrome

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

Nephrology Unit of the University Children's Hospital Zurich

Zurich, CH-8032, Switzerland

Location

Related Publications (9)

• Neuhaus TJ, Calonder S, Leumann EP. Heterogeneity of atypical haemolytic uraemic syndromes. Arch Dis Child. 1997 Jun;76(6):518-21. doi: 10.1136/adc.76.6.518.

  PMID: 9245850 BACKGROUND

• 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. doi: 10.1007/s00467-003-1337-4. Epub 2003 Nov 27.

  PMID: 14648326 BACKGROUND

• Ruth 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. doi: 10.1016/j.jpeds.2004.08.022.

  PMID: 15580200 BACKGROUND

• 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.

  PMID: 18389283 BACKGROUND

• Falger J, Landolt MA, Latal B, Ruth 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.

  PMID: 18386069 BACKGROUND

• Schifferli A, von Vigier RO, Fontana M, Sparta 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.

  PMID: 19830454 BACKGROUND

• 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.

  PMID: 19567766 BACKGROUND

• 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. doi: 10.1136/adc.80.3.214.

  PMID: 10325699 BACKGROUND

• Buder K, Werner H, Landolt MA, Neuhaus TJ, Laube GF, Sparta G. Health-related quality of life and mental health in parents of children with hemolytic uremic syndrome. Pediatr Nephrol. 2016 Jun;31(6):923-32. doi: 10.1007/s00467-015-3294-0. Epub 2015 Dec 23.

  PMID: 26701835 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Hemolytic-Uremic Syndrome

Condition Hierarchy (Ancestors)

Uremia; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia

Study Officials

• Giuseppina Spartà, MD

  Nephrology Unit, University Children's Hospital, Zurich, Steinwiesstrasse 75, CH-8032 Zürich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 16, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

CH (1)