Prevalence of Hemolytic Uremic SyndromeNCT07171749
Prevalence of Hemolytic Uremic Syndrome (HUS) in Pediatrics
An observational study of Prevalence of Hemolytic Uremic Syndrome, run by Assiut University.
Trial summary
To determine the prevalence of hemolytic uremic syndrome (HUS) among pediatric patients admitted to Assiut University Children's Hospital, and to describe the demographic, clinical, and laboratory characteristics of the affected population. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Prevalence of Hemolytic Uremic Syndrome
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day to 18 years
- All sexes
- Child, Adult
Study population: Pediatric patients (aged <18 years) who were diagnosed with hemolytic uremic syndrome (HUS) and admitted to Assiut University Children's Hospital during the period from 1 October 2025 to 30 September 2026.
Who may be able to join
- Patients aged below 18 years at the time of diagnosis.
- Confirmed diagnosis of HUS based on the clinical triad (microangiopathic hemolytic anemia, thrombocytopenia, and acute kidney injury).
Who cannot join
- Patients aged 18 years or above at the time of diagnosis.
- Incomplete or missing medical records that do not confirm the diagnosis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevalence of Hemolytic Uremic Syndrome (HUS) in Pediatrics at Assiut University Children's Hospital: A Prospective Study
To determine the prevalence of hemolytic uremic syndrome (HUS) among pediatric patients admitted to Assiut University Children's Hospital, and to describe the demographic, clinical, and laboratory characteristics of the affected population.
Read the detailed description
Hemolytic uremic syndrome (HUS) is a rare but serious condition characterized by the triad of microangiopathic hemolytic anemia, thrombocytopenia, and acute kidney injury. [1] Two main subtypes of HUS are recognized. The majority of pediatric cases are classified as typical HUS, most frequently associated with Shiga toxin-producing Escherichia coli (STEC) infection. In contrast, atypical HUS (aHUS) is less common, accounting for approximately 5-10% of cases, and is linked to dysregulation of the complement system. The clinical course and prognosis differ significantly between these subtypes.[2].
Understanding the prevalence of HUS is critical for early recognition and timely intervention, especially in resource-limited settings. [3] Complications of HUS can be severe and include neurological manifestations, hypertension, persistent renal impairment, and in some cases, death. Early diagnosis and supportive care are critical for improved outcomes [4].
Local factors such as water safety, sanitation, access to early antibiotics, and public health surveillance greatly affect the observed prevalence. [5] The management of typical HUS caused by STEC is generally supportive. [6] For aHUS, early treatment is crucial to avoid end-stage renal disease (ESRD) and mortality. The cornerstones of treatment for aHUS are first-line therapy with eculizumab [7]
- Conditions
- Prevalence of Hemolytic Uremic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Hemolytic Uremic Syndrome (HUS) among Pediatric Patients
The proportion of pediatric patients diagnosed with HUS out of the total number of children admitted to Assiut University Children's Hospital during the study period. Diagnosis will be based on clinical, laboratory, and imaging criteria.
Measured: Within 12months of enrollment (october 2025-September 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Prevalence of Hemolytic Uremic SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Ali Abdelmawgoud Abd Elgied, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171749
- Sponsor's protocol ID
- Prevelance of HUS
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Franchini M. Atypical hemolytic uremic syndrome: from diagnosis to treatment. Clin Chem Lab Med. 2015 Oct;53(11):1679-88. doi: 10.1515/cclm-2015-0024.
PubMed 25803082Joseph A, Cointe A, Mariani Kurkdjian P, Rafat C, Hertig A. Shiga Toxin-Associated Hemolytic Uremic Syndrome: A Narrative Review. Toxins (Basel). 2020 Jan 21;12(2):67. doi: 10.3390/toxins12020067.
PubMed 31973203Jenssen GR, Hovland E, Bjerre A, Bangstad HJ, Nygard K, Vold L. Incidence and etiology of hemolytic-uremic syndrome in children in Norway, 1999-2008--a retrospective study of hospital records to assess the sensitivity of surveillance. BMC Infect Dis. 2014 May 16;14:265. doi: 10.1186/1471-2334-14-265.
PubMed 24884396Yerigeri K, Kadatane S, Mongan K, Boyer O, Burke LLG, Sethi SK, Licht C, Raina R. Atypical Hemolytic-Uremic Syndrome: Genetic Basis, Clinical Manifestations, and a Multidisciplinary Approach to Management. J Multidiscip Healthc. 2023 Aug 4;16:2233-2249. doi: 10.2147/JMDH.S245620. eCollection 2023.
PubMed 37560408Zagozdzon I, Szczepanska M, Leszczynska B, Jarmuzek W, Miklaszewska M, Tkaczyk M, Medynska A, Wieczorkiewicz-Plaza A, Zachwieja J, Protas P, Rosinska P, Jacher U, Trembecka-Dubel E, Zwolinska D, Zurowska A. Changing Epidemiology and Outcomes of Hemolytic Uremic Syndrome in Children: A Prospective National Cohort Study from the Polish Pediatric HUS Registry and the Polish Registry of Renal Replacement Therapy in Children. J Clin Med. 2024 Oct 30;13(21):6499. doi: 10.3390/jcm13216499.
PubMed 39518638McKee RS, Schnadower D, Tarr PI, Xie J, Finkelstein Y, Desai N, Lane RD, Bergmann KR, Kaplan RL, Hariharan S, Cruz AT, Cohen DM, Dixon A, Ramgopal S, Rominger A, Powell EC, Kilgar J, Michelson KA, Beer D, Bitzan M, Pruitt CM, Yen K, Meckler GD, Plint AC, Bradin S, Abramo TJ, Gouin S, Kam AJ, Schuh A, Balamuth F, Hunley TE, Kanegaye JT, Jones NE, Avva U, Porter R, Fein DM, Louie JP, Freedman SB; Pediatric Emergency Medicine Collaborative Research Committee and Pediatric Emergency Research Canada. Predicting Hemolytic Uremic Syndrome and Renal Replacement Therapy in Shiga Toxin-producing Escherichia coli-infected Children. Clin Infect Dis. 2020 Apr 10;70(8):1643-1651. doi: 10.1093/cid/ciz432.
PubMed 31125419Bayer G, von Tokarski F, Thoreau B, Bauvois A, Barbet C, Cloarec S, Merieau E, Lachot S, Garot D, Bernard L, Gyan E, Perrotin F, Pouplard C, Maillot F, Gatault P, Sautenet B, Rusch E, Buchler M, Vigneau C, Fakhouri F, Halimi JM. Etiology and Outcomes of Thrombotic Microangiopathies. Clin J Am Soc Nephrol. 2019 Apr 5;14(4):557-566. doi: 10.2215/CJN.11470918. Epub 2019 Mar 12.
PubMed 30862697Beczkiewicz ATE, Scharff RL, Kowalcyk BB. Facilitating Evaluation of Hemolytic Uremic Syndrome Long-Term Health Outcomes Through Social Media Support Groups. Front Public Health. 2020 Nov 23;8:544154. doi: 10.3389/fpubh.2020.544154. eCollection 2020.
PubMed 33330302Alconcher LF, Lucarelli LI, Bronfen S. Long-term kidney outcomes in non-dialyzed children with Shiga-toxin Escherichia coli associated hemolytic uremic syndrome. Pediatr Nephrol. 2023 Jul;38(7):2131-2136. doi: 10.1007/s00467-022-05851-4. Epub 2023 Jan 3.
PubMed 36595068Ardissino G, Longhi S, Porcaro L, Pintarelli G, Strumbo B, Capone V, Cresseri D, Loffredo G, Tel F, Salardi S, Sgarbanti M, Martelli L, Rodrigues EM, Borsa-Ghiringhelli N, Montini G, Seia M, Cugno M, Carfagna F, Consonni D, Tedeschi S. Risk of Atypical HUS Among Family Members of Patients Carrying Complement Regulatory Gene Abnormality. Kidney Int Rep. 2021 Mar 25;6(6):1614-1621. doi: 10.1016/j.ekir.2021.03.885. eCollection 2021 Jun.
PubMed 34169201
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hemolytic Uremic Syndrome (HUS) in Pediatrics at Assiut University Children's Hospital: A Prospective Study
- ClinicalTrials.gov ID
- NCT07171749
- Acronym / sponsor ID
- Prevelance of HUS
- Conditions
- Prevalence of Hemolytic Uremic Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 15 Sep 2025 (actual)
- 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.
To determine the prevalence of hemolytic uremic syndrome (HUS) among pediatric patients admitted to Assiut University Children's Hospital, and to describe the demographic, clinical, and laboratory characteristics of the affected population.
Detailed description
Hemolytic uremic syndrome (HUS) is a rare but serious condition characterized by the triad of microangiopathic hemolytic anemia, thrombocytopenia, and acute kidney injury. [1] Two main subtypes of HUS are recognized. The majority of pediatric cases are classified as typical HUS, most frequently associated with Shiga toxin-producing Escherichia coli (STEC) infection. In contrast, atypical HUS (aHUS) is less common, accounting for approximately 5-10% of cases, and is linked to dysregulation of the complement system. The clinical course and prognosis differ significantly between these subtypes.[2].
Understanding the prevalence of HUS is critical for early recognition and timely intervention, especially in resource-limited settings. [3] Complications of HUS can be severe and include neurological manifestations, hypertension, persistent renal impairment, and in some cases, death. Early diagnosis and supportive care are critical for improved outcomes [4].
Local factors such as water safety, sanitation, access to early antibiotics, and public health surveillance greatly affect the observed prevalence. [5] The management of typical HUS caused by STEC is generally supportive. [6] For aHUS, early treatment is crucial to avoid end-stage renal disease (ESRD) and mortality. The cornerstones of treatment for aHUS are first-line therapy with eculizumab [7]
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric patients (aged <18 years) who were diagnosed with hemolytic uremic syndrome (HUS) and admitted to Assiut University Children's Hospital during the period from 1 October 2025 to 30 September 2026.
Key inclusion criteria (2 listed)
- Patients aged below 18 years at the time of diagnosis.
- Confirmed diagnosis of HUS based on the clinical triad (microangiopathic hemolytic anemia, thrombocytopenia, and acute kidney injury).
Key exclusion criteria (2 listed)
- Patients aged 18 years or above at the time of diagnosis.
- Incomplete or missing medical records that do not confirm the diagnosis.
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
Prevalence of Hemolytic Uremic Syndrome (HUS) among Pediatric Patients
Time frame: Within 12months of enrollment (october 2025-September 2026)
The proportion of pediatric patients diagnosed with HUS out of the total number of children admitted to Assiut University Children's Hospital during the study period. Diagnosis will be based on clinical, laboratory, and imaging criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Results publication: PubMed 25803082Franchini M. Atypical hemolytic uremic syndrome: from diagnosis to treatment. Clin Chem Lab Med. 2015 Oct;53(11):1679-88. doi: 10.1515/cclm-2015-0024.
- Results publication: PubMed 31973203Joseph A, Cointe A, Mariani Kurkdjian P, Rafat C, Hertig A. Shiga Toxin-Associated Hemolytic Uremic Syndrome: A Narrative Review. Toxins (Basel). 2020 Jan 21;12(2):67. doi: 10.3390/toxins12020067.
- Results publication: PubMed 24884396Jenssen GR, Hovland E, Bjerre A, Bangstad HJ, Nygard K, Vold L. Incidence and etiology of hemolytic-uremic syndrome in children in Norway, 1999-2008--a retrospective study of hospital records to assess the sensitivity of surveillance. BMC Infect Dis. 2014 May 16;14:265. doi: 10.1186/1471-2334-14-265.
- Results publication: PubMed 37560408Yerigeri K, Kadatane S, Mongan K, Boyer O, Burke LLG, Sethi SK, Licht C, Raina R. Atypical Hemolytic-Uremic Syndrome: Genetic Basis, Clinical Manifestations, and a Multidisciplinary Approach to Management. J Multidiscip Healthc. 2023 Aug 4;16:2233-2249. doi: 10.2147/JMDH.S245620. eCollection 2023.
- Results publication: PubMed 39518638Zagozdzon I, Szczepanska M, Leszczynska B, Jarmuzek W, Miklaszewska M, Tkaczyk M, Medynska A, Wieczorkiewicz-Plaza A, Zachwieja J, Protas P, Rosinska P, Jacher U, Trembecka-Dubel E, Zwolinska D, Zurowska A. Changing Epidemiology and Outcomes of Hemolytic Uremic Syndrome in Children: A Prospective National Cohort Study from the Polish Pediatric HUS Registry and the Polish Registry of Renal Replacement Therapy in Children. J Clin Med. 2024 Oct 30;13(21):6499. doi: 10.3390/jcm13216499.
- Results publication: PubMed 31125419McKee RS, Schnadower D, Tarr PI, Xie J, Finkelstein Y, Desai N, Lane RD, Bergmann KR, Kaplan RL, Hariharan S, Cruz AT, Cohen DM, Dixon A, Ramgopal S, Rominger A, Powell EC, Kilgar J, Michelson KA, Beer D, Bitzan M, Pruitt CM, Yen K, Meckler GD, Plint AC, Bradin S, Abramo TJ, Gouin S, Kam AJ, Schuh A, Balamuth F, Hunley TE, Kanegaye JT, Jones NE, Avva U, Porter R, Fein DM, Louie JP, Freedman SB; Pediatric Emergency Medicine Collaborative Research Committee and Pediatric Emergency Research Canada. Predicting Hemolytic Uremic Syndrome and Renal Replacement Therapy in Shiga Toxin-producing Escherichia coli-infected Children. Clin Infect Dis. 2020 Apr 10;70(8):1643-1651. doi: 10.1093/cid/ciz432.
- Results publication: PubMed 30862697Bayer G, von Tokarski F, Thoreau B, Bauvois A, Barbet C, Cloarec S, Merieau E, Lachot S, Garot D, Bernard L, Gyan E, Perrotin F, Pouplard C, Maillot F, Gatault P, Sautenet B, Rusch E, Buchler M, Vigneau C, Fakhouri F, Halimi JM. Etiology and Outcomes of Thrombotic Microangiopathies. Clin J Am Soc Nephrol. 2019 Apr 5;14(4):557-566. doi: 10.2215/CJN.11470918. Epub 2019 Mar 12.
- Results publication: PubMed 33330302Beczkiewicz ATE, Scharff RL, Kowalcyk BB. Facilitating Evaluation of Hemolytic Uremic Syndrome Long-Term Health Outcomes Through Social Media Support Groups. Front Public Health. 2020 Nov 23;8:544154. doi: 10.3389/fpubh.2020.544154. eCollection 2020.
- Results publication: PubMed 36595068Alconcher LF, Lucarelli LI, Bronfen S. Long-term kidney outcomes in non-dialyzed children with Shiga-toxin Escherichia coli associated hemolytic uremic syndrome. Pediatr Nephrol. 2023 Jul;38(7):2131-2136. doi: 10.1007/s00467-022-05851-4. Epub 2023 Jan 3.
- Results publication: PubMed 34169201Ardissino G, Longhi S, Porcaro L, Pintarelli G, Strumbo B, Capone V, Cresseri D, Loffredo G, Tel F, Salardi S, Sgarbanti M, Martelli L, Rodrigues EM, Borsa-Ghiringhelli N, Montini G, Seia M, Cugno M, Carfagna F, Consonni D, Tedeschi S. Risk of Atypical HUS Among Family Members of Patients Carrying Complement Regulatory Gene Abnormality. Kidney Int Rep. 2021 Mar 25;6(6):1614-1621. doi: 10.1016/j.ekir.2021.03.885. eCollection 2021 Jun.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevalence of Hemolytic Uremic Syndrome, run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hala Ali Abdel Mawgoud, Principal-investigator (+2001091108665, Hala.17289886@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Hemolytic Uremic Syndrome (HUS) among Pediatric Patients (time frame: Within 12months of enrollment (october 2025-September 2026)). 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 NCT07171749, which also lists 10 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 15 Sep 2025.