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

Hemolytic Uremic Syndrome of Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03690024
• Other study ID #: Ocwhus
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: September 2018
• Source: Assiut University
• Contact: Fahim Mohamed Fahim, Professor
• Phone: 01002500073
• Email: fahim.osman[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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) . 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.

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].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Azotemia
• Hemolysis
• Hemolytic Uremic Syndrome of Childhood
• Hemolytic-Uremic Syndrome
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission	Number of cases that treated and discharged from hospital	1 year
Primary	Death	Number of cases that ended by death	1 year
Primary	Residual renal affection	Number of cases with residual raised renal chemistry	1 year