Hemolytic-Uremic SyndromeNCT01666548
Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects
An observational study of Hemolytic-Uremic Syndrome and Children, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Hemolytic-Uremic Syndrome, Children, Parents
- How many people
- 89 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: children and youth from 2 months to 17 years in who had suffered from haemolytic uraemic syndrome
Who may be able to join
- 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
Who cannot join
- missing written informed consent
- children who do not fulfil the age criterion
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Nephrology Unit of the University Children's Hospital Zurich
Zurich, CH-8032
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Hemolytic-Uremic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
- renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood
Measured: 1 year 5 months
- quality of life of children with haemolytic uraemic syndrome and their parents
Measured: 1 year 5 months
- neuropsychological sequelae of children with haemolytic uraemic syndrome
Measured: 1 year 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hemolytic-Uremic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppina Spartà, MD, Principal investigator, Nephrology Unit, University Children's Hospital, Zurich, Steinwiesstrasse 75, CH-8032 Zürich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666548
- Sponsor's protocol ID
- KEK-ZH-Nr. 2011-0394
- Status last verified
- Sep 2013
- First submitted
- 31 Jul 2012
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9245850Brunner 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.
PubMed 14648326Ruth 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.
PubMed 15580200Falger 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.
PubMed 18389283Falger 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.
PubMed 18386069Schifferli 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.
PubMed 19830454Pollock 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.
PubMed 19567766Schlieper 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.
PubMed 10325699Buder 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.
PubMed 26701835
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects
- ClinicalTrials.gov ID
- NCT01666548
- Acronym / sponsor ID
- KEK-ZH-Nr. 2011-0394
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children and youth from 2 months to 17 years in who had suffered from haemolytic uraemic syndrome
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- missing written informed consent
- children who do not fulfil the age criterion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
- renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood
Time frame: 1 year 5 months
- quality of life of children with haemolytic uraemic syndrome and their parents
Time frame: 1 year 5 months
- neuropsychological sequelae of children with haemolytic uraemic syndrome
Time frame: 1 year 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Background: PubMed 9245850Neuhaus 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.
- Background: PubMed 14648326Brunner 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.
- Background: PubMed 15580200Ruth 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.
- Background: PubMed 18389283Falger 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.
- Background: PubMed 18386069Falger 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.
- Background: PubMed 19830454Schifferli 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.
- Background: PubMed 19567766Pollock 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.
- Background: PubMed 10325699Schlieper 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.
- Derived from this study: PubMed 26701835Buder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppina Spartà, MD principal investigator
Nephrology Unit, University Children's Hospital, Zurich, Steinwiesstrasse 75, CH-8032 Zürich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemolytic-Uremic Syndrome and Children, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- renal function (estimated glomerular filtration rate according to the SCHWARTZ formula) after haemolytic uraemic syndrome in childhood (time frame: 1 year 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01666548, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.