ClinicalTrials.gg
Status unknownNCT03690024Updated Oct 1, 2018

Outcame of Cases With Hemolytic Uremic Syndrome Attending Assiut University Child Hospital

An observational study in Hemolytic Uremic Syndrome of Childhood, sponsored by Assiut University. Status unknown. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2018-10-01.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Not yet recruiting — may be out of date.

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
Up to 18 Years
Sex
All
01

Study summary

Diarrhea-associated hemolytic uremic syndrome (D+HUS) is defined as a prodrome of enteritis followed by thrombocytopenia (\< 150,000/mm3), microangiopathic hemolytic anemia, and signs of variable degrees of renal damage (increase in serum Cr, proteinuria, and/or hematuria) . Our aim is to detect the most reliable early predictors of poor prognosis to identify children at major risk of bad outcome who could eventually benefit from early specific treatments.

Read the detailed description

The disease is caused predominantly by Shiga toxin-producing enterohemorrhagic Escherichia coli (STEC) and is one of the most common etiologies of acute kidney injury (AKI) and an important cause of acquired chronic kidney disease in children [2]. The incidence of HUC tends to parallel the seasonal fluctuation of E.coli o175 : H7 infection which peaks between June \& September. Nowadays, the incidence increases and is typically observe in infants and children, especially those aged 6 months to 4 years. A complicated disease course is defined as the development of one or more of the following manifestations: neurological dysfunction, severe bowel injury, pancreatitis, hemodynamic instability (symptomatic hypotension, multi-organ failure), cardiac (congestive heart failure, myocarditis, pericarditis, arrhythmia) or pulmonary involvement (pulmonary edema, acute respiratory distress syndrome), hematologic complications (hemorrhage), and death [1].

Many laboratory and clinical markers upon admission have been associated to severe forms of the disease, including high initial leukocyte and hematocrit levels, major extrarenal complications, dehydration and recently, the blood urea nitrogen (BUN) to serum creatinine (Cr) ratio [1], [4-6]. Treatment of D+HUS remains supportive; thus, early identification of high-risk patients can optimize their management [1-3].

02

Conditions studied

  • Hemolytic Uremic Syndrome of Childhood
03

In context

Hemolytic-Uremic Syndrome

28 studies on the registry are indexed under Hemolytic-Uremic Syndrome; 7 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 13 observational studies indexed under Hemolytic-Uremic Syndrome.

Browse Hemolytic-Uremic Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients attending Assiut University Child hospital

Eligibility criteria

Inclusion Criteria:

  • all patients less than 18 years diagnosed with Hemolytic Uremic Syndrome
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Complete remission

    Number of cases that treated and discharged from hospital

    Time frame: 1 year

  2. Death

    Number of cases that ended by death

    Time frame: 1 year

  3. Residual renal affection

    Number of cases with residual raised renal chemistry

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2018; primary completion for Oct 2019, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2018
First posted
Oct 1, 2018
StartEst.
Oct 1, 2018
Primary completionEst.
Oct 1, 2019
CompletionEst.
Dec 1, 2019
Last update
Oct 1, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03690024
Lead sponsor
Assiut University
Responsible party
walaa gamal abd elrazik (Principal investigator, Assiut University) — Principal investigator
First posted
Oct 1, 2018
Start date
Oct 1, 2018 (estimated)
Primary completion
Oct 1, 2019 (estimated)
Completion
Dec 1, 2019 (estimated)
Last update
Oct 1, 2018

Study contacts

Fahim Mohamed Fahim, Professor
Contact
fahim.osman@med.au.edu.eg
01002500073 ext. 002
Ahlam Badawy Ali Badawy, Ph.D.
Contact
drahlamali@aun.edu.eg
01006807866 ext. 002

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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