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

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03690024

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Outcome Measures

Primary Outcome Measures

Complete remission [1 year]
Number of cases that treated and discharged from hospital
Death [1 year]
Number of cases that ended by death
Residual renal affection [1 year]
Number of cases with residual raised renal chemistry

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

all patients less than 18 years diagnosed with Hemolytic Uremic Syndrome

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

walaa gamal abd elrazik, Principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT03690024

Other Study ID Numbers:

Ocwhus

First Posted:

Oct 1, 2018

Last Update Posted:

Oct 1, 2018

Last Verified:

Sep 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Azotemia

Hemolytic-Uremic Syndrome

Syndrome

Hemolysis

Study Results

No Results Posted as of Oct 1, 2018