Hemolytic Uremic Syndrome of ChildhoodNCT03690024
Outcame of Cases With Hemolytic Uremic Syndrome Attending Assiut University Child Hospital
An observational study of Hemolytic Uremic Syndrome of Childhood, run by Assiut University.
Trial 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) . Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hemolytic Uremic Syndrome of Childhood
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Dec 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients attending Assiut University Child hospital
Who may be able to join
- all patients less than 18 years diagnosed with Hemolytic Uremic Syndrome
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
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].
- Conditions
- Hemolytic Uremic Syndrome of Childhood
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission
Number of cases that treated and discharged from hospital
Measured: 1 year
Death
Number of cases that ended by death
Measured: 1 year
Residual renal affection
Number of cases with residual raised renal chemistry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemolytic Uremic Syndrome of ChildhoodStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa gamal abd elrazik, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690024
- Sponsor's protocol ID
- Ocwhus
- Status last verified
- Sep 2018
- First submitted
- 26 Sep 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcame of Cases With Hemolytic Uremic Syndrome Attending Assiut University Child Hospital
- ClinicalTrials.gov ID
- NCT03690024
- Acronym / sponsor ID
- Ocwhus
- Conditions
- Hemolytic Uremic Syndrome of Childhood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 1 Oct 2018 (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.
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.
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].
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients attending Assiut University Child hospital
Key inclusion criteria (1 listed)
- all patients less than 18 years diagnosed with Hemolytic Uremic Syndrome
Key exclusion criteria (0 listed)
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
Complete remission
Time frame: 1 year
Number of cases that treated and discharged from hospital
Death
Time frame: 1 year
Number of cases that ended by death
Residual renal affection
Time frame: 1 year
Number of cases with residual raised renal chemistry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemolytic Uremic Syndrome of Childhood, 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 1 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fahim Mohamed Fahim, Professor (01002500073 ext. 002, fahim.osman@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (time frame: 1 year). 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?
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 1 Oct 2018.