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

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.

Study Overview

• Status: Unknown
• Conditions: Hemolytic Uremic Syndrome of Childhood

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Fahim Mohamed Fahim, Professor; Phone Number: 002 01002500073; Email: fahim.osman@med.au.edu.eg
• Study Contact Backup: Name: Ahlam Badawy Ali Badawy, Ph.D.; Phone Number: 002 01006807866; Email: drahlamali@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients attending Assiut University Child hospital

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete remission	Number of cases that treated and discharged from hospital	1 year
Death	Number of cases that ended by death	1 year
Residual renal affection	Number of cases with residual raised renal chemistry	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2018
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (ACTUAL): October 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2018
• Last Update Submitted That Met QC Criteria: September 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease; Hematologic Diseases; Anemia; Thrombocytopenia; Blood Platelet Disorders; Anemia, Hemolytic; Thrombotic Microangiopathies; Uremia; Syndrome; Azotemia; Hemolysis; Hemolytic-Uremic Syndrome
• Other Study ID Numbers: Ocwhus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No