<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01666548</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH-Nr. 2011-0394</org_study_id>
    <nct_id>NCT01666548</nct_id>
  </id_info>
  <brief_title>Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects</brief_title>
  <official_title>Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Children's Hospital, Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Children's Hospital, Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the clinical, cognitive outcome and psychosocial&#xD;
      outcome of haemolytic uraemic syndrome in childhood.&#xD;
&#xD;
      The haemolytic uraemic syndrome (HUS) is the leading cause of acute renal failure in&#xD;
      childhood. The more common typical HUS is mostly caused by Shigatoxin-producing&#xD;
      enterohaemorrhagic Escherichia coli (EHEC). The rarer atypical HUS is mainly caused by&#xD;
      different genetic abnormalities in complement regulatory proteins.&#xD;
&#xD;
      About 50 till 60 percent of all patients with HUS develop a severe acute renal failure and&#xD;
      require dialysis. Resulting from new diagnostic and therapeutic approaches the survival rate&#xD;
      increased during the last years. Despite this, there are only few data concerning long-term&#xD;
      prognosis, cognitive and motoric development, as well as psychological coping and&#xD;
      health-related quality of life of affected children and their parents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purposes of this study are: the evaluation of the long-term renal function of&#xD;
      pediatric HUS-patients; the evaluation of the dialysis method in the acute phase of the&#xD;
      disease and its impact on the duration of the renal-placement-therapy, as well as the&#xD;
      long-term renal function; the evaluation of the intellectual and motoric performance of&#xD;
      affected children and the evaluation of the health-related quality of life and psychological&#xD;
      processing of the patients themselves and their parents.&#xD;
&#xD;
      All cases of HUS treated at the University Children's Hospital Zurich between 1995 and 2012&#xD;
      will be analyzed retrospectively. In the course of a routine-follow-up-examination the&#xD;
      clinical data of patients up to the age of 17 years will be actualized and completed. The&#xD;
      results of clinical and paraclinical investigations related to renal function will be&#xD;
      evaluated to describe the clinical features of haemolytic uraemic syndrome in childhood.&#xD;
&#xD;
      Intellectual performance will be analyzed with the Wechsler-Intelligence Scale for&#xD;
      Children-IV (WISC-IV) and motoric performance with the Zurich Neuromotor Assessment in&#xD;
      children at the age from 6 to 16 years.&#xD;
&#xD;
      The health-related quality-of-life of all parents and affected children from the age of 7&#xD;
      years will be assessed by different generic quality-of-life-instruments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>- renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood</measure>
    <time_frame>1 year 5 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>- quality of life of children with haemolytic uraemic syndrome and their parents</measure>
    <time_frame>1 year 5 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>- neuropsychological sequelae of children with haemolytic uraemic syndrome</measure>
    <time_frame>1 year 5 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">89</enrollment>
  <condition>Hemolytic-Uremic Syndrome</condition>
  <condition>Children</condition>
  <condition>Parents</condition>
  <condition>Psychological Adjustment</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      urine, native-blood, blood plasma, EDTA stabilized blood, heparin blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        children and youth from 2 months to 17 years in who had suffered from haemolytic uraemic&#xD;
        syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children and youth from 2 months to 17 years who had suffered from haemolytic uraemic&#xD;
             syndrome&#xD;
&#xD;
          -  willingness and ability to participate in the study&#xD;
&#xD;
          -  freely signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  missing written informed consent&#xD;
&#xD;
          -  children who do not fulfil the age criterion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giuseppina Spartà, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nephrology Unit, University Children's Hospital, Zurich, Steinwiesstrasse 75, CH-8032 Zürich, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nephrology Unit of the University Children's Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>CH-8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>9245850</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14648326</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15580200</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18389283</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18386069</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19830454</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19567766</PMID>
  </reference>
  <reference>
    <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. doi: 10.1136/adc.80.3.214.</citation>
    <PMID>10325699</PMID>
  </reference>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>July 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>September 3, 2013</last_update_submitted>
  <last_update_submitted_qc>September 3, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>haemolytic uraemic syndrome</keyword>
  <keyword>complications of HUS</keyword>
  <keyword>renal replacement treatment</keyword>
  <keyword>renal function outcome</keyword>
  <keyword>neuropsychological sequelae</keyword>
  <keyword>psychological adjustment</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azotemia</mesh_term>
    <mesh_term>Hemolytic-Uremic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01666548
org study id: KEK-ZH-Nr. 2011-0394
nct id: NCT01666548
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Retrospective
measure: - renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood
time frame: 1 year 5 months
measure: - quality of life of children with haemolytic uraemic syndrome and their parents
time frame: 1 year 5 months
measure: - neuropsychological sequelae of children with haemolytic uraemic syndrome
time frame: 1 year 5 months
urine, native-blood, blood plasma, EDTA stabilized blood, heparin blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Months
maximum age: 17 Years
healthy volunteers: No
last name: Giuseppina Spartà, MD
role: Principal Investigator
affiliation: Nephrology Unit, University Children's Hospital, Zurich, Steinwiesstrasse 75, CH-8032 Zürich, Switzerland
facility: 
country: Switzerland
citation: 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
citation: 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
citation: 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
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.
PMID: 18389283
citation: 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
citation: 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
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.
PMID: 19567766
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. doi: 10.1136/adc.80.3.214.
PMID: 10325699
responsible party type: Sponsor
mesh term: Azotemia
mesh term: Hemolytic-Uremic Syndrome
mesh term: Syndrome