- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517939
What Are the Predictors of Acute Kidney Injury in Children Admitted to Pediatrics Intensive Care Unit at Assiut University Children Hospital?
Predictors of Acute Kidneyinjury in Children Admitted to Pediatrics Intensive Care Unit at Assiut University ChildrenHospital
Study Overview
Status
Intervention / Treatment
Detailed Description
Acute kidney injury (AKI) is defined by a sudden loss of excretory kidney function. AKI is part of a range of conditions summarized as acute kidney diseases and disorders (AKD), in which slow deterioration of kidney function or persistent kidney dysfunction is associated with an irreversible loss of kidney cells and nephrons, which can lead to chronic kidney disease AKI is determined by increased serum creatinine levels >0.3 mg/dl (a marker of kidney excretory function) and reduced urinary output <0.5 ml/Kg for more than 8 h (a quantitative marker of urine production) and is limited to a duration of 7 days and when lasts for>3months is referred to as chronic kidney disease (CKD).Acute kidney injury (AKI) is associated with poor outcome in critically ill children.The reported incidence rate of AKI in children admitted to pediatric intensive care units (PICUs) ranges from 8% and 89% worldwide. Stage 1 was identified in 24.24% of the AKI cases, stage 2 in 31.03% and stage 3 in 44.71%. The most prevalent cause of AKI was represented by prerenal AKI in 85.64% of the cases, followed by 12.16% renal causes respectively 2.18% postrenal causes.
Symptoms of an AKI come on suddenly, over the course of hours or days. They depend on the underlying cause, but some of the most common symptoms include hematuria, fever, rash, bloody diarrhea, severe vomiting, abdominal pain, no urine output or high urine output, pale skin. oedema, puffy eyes and detectable abdominal mass. stages of Acute Kidney Injury .A standardized definition of AKI was proposed by the Kidney Disease: ImprovIng Global Outcomes (KDIGO) AKI working group in 2012 and has been validated In pediatric populations subsequently. This definition identifies and stages AKI Based on changes in serum creatinine from baseline or urine output as detailed .
Stage 1 Serum creatinine increase by 1.5-1.9 times baseline within 7 days or increase by ≥0.3 mg/dL (26.5 μmol/L) within 48 hours Urine output is less than 0.5 mL/kg/h for 6 - 12 hours Stage 2 Serum creatinine increase by 2-2.9 times baseline Urine output is less than 0.5 mLkg/h for >12 hours Stage 3 Serum creatinine increase by ≥3 times baseline or increase to≥ 4 mg/dL (353.6 μmol/L) or renal replacement therapy initiation or in patients younger than 18 years decrease in estimated GFR to <35 mL/min/1.73 m2 Urine output is less than 0.3 ml/kg/h for ≥24 h or anuria for ≥12h There are many predisposing factors that lead to AKI for such as gastroenteritis, presence of infection, sepsis, shock, cardiac disease, mechanical ventilation hypoxia and coagulopathy are important predictors for AKI. Despite significant developments in the management of AKI, the overall mortality rate of patients with AKI has not improved dramatically. The most widely available studies deal primarily with AKI, reporting mortality rates between 11% and 63% in pediatric patients. Outcomes among children who develop acute kidney injury (AKI). Children who develop AKI while hospitalized are at risk for poorer short-and mid/long-term outcomes. Across both acute and critical care populations, AKI is associated with longer lengths of stay, non-recovery of baseline renal function, and chronic renal disease including proteinuria hypertension, and chronic kidney disease (CKD).
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All cases of acute kidney injury in pediatrics from 1 month to 18years who admitted to PICU Assiut University Children Hospital according to (KDIGO) AKI Staging criteria during the duration of the study.
Exclusion Criteria:
- Neonates
- patients above 18 years of age
- patients with chronic kidney disease
- patients with renal malformations
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of acute kidney injury (AKI) associated with sepsis and related clinical risk factors.
Time Frame: One year
|
Detection of clinical risk factors including sepsis, septic shock, pre-existing comorbidities, mechanical ventilation, and use of inotropes among hospitalized patients.
|
One year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AKI in ICU children
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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