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Not yet recruiting NCT07171749

Prevalence of Hemolytic Uremic Syndrome (HUS) in Pediatrics

Observational Prevalence of Hemolytic Uremic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Prevalence of Hemolytic Uremic Syndrome. Basic parameters: 1 Day — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prevalence of Hemolytic Uremic Syndrome (HUS) in Pediatrics at Assiut University Children's Hospital: A Prospective Study

Overview

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 \[7\]

Primary outcome measures

  • Prevalence of Hemolytic Uremic Syndrome (HUS) among Pediatric Patients [Time frame: Within 12months of enrollment (october 2025-September 2026)]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • Patients aged 18 years or above at the time of diagnosis.
  • Incomplete or missing medical records that do not confirm the diagnosis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 25803082
  • Joseph 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. PMID 31973203
  • Jenssen 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. PMID 24884396
  • Yerigeri 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. PMID 37560408
  • Zagozdzon 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 Replacem PMID 39518638
  • McKee 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; Pe PMID 31125419
  • Bayer 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. PMID 30862697
  • Beczkiewicz 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. PMID 33330302

Identifiers

NCT: NCT07171749 · Prevelance of HUS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗