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AKINCT07517939

What Are the Predictors of Acute Kidney Injury in Children Admitted to Pediatrics Intensive Care Unit at Assiut University Children Hospital?

An observational study of AKI and ICU, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Identify the Predictors of Acute Kidney Injury in critically ill children admitted to PICU during one year Read more about this study

Who is it for?
Ages 1 month to 18 years
Conditions the study is for
AKI, ICU
What is being tested?
Clinical and laboratory assessment
How many people
100 participants
Where
No sites listed yet
Study dates
1 May 2026to 1 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 1 month to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: acute kidney injury in pediatrics from 1 month to 18years

Who may be able to join

  • 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.

Who cannot join

  • Neonates
  • patients above 18 years of age
  • patients with chronic kidney disease
  • patients with renal malformations

About this study

Official title: Predictors of Acute Kidneyinjury in Children Admitted to Pediatrics Intensive Care Unit at Assiut University ChildrenHospital

Identify the Predictors of Acute Kidney Injury in critically ill children admitted to PICU during one year

Read the 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).

Conditions
AKI, ICU
Being tested
Clinical and laboratory assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical and laboratory assessmentOther

    Clinical history taking, physical examination including daily fluid intake and urine output monitoring, laboratory investigations (CBC, renal function tests, electrolytes, ESR, urine analysis and culture, 24-hour urinary protein, serum proteins, ASO titer, C3 and C4), and renal ultrasonography.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of acute kidney injury (AKI) associated with sepsis and related clinical risk factors.

    Detection of clinical risk factors including sepsis, septic shock, pre-existing comorbidities, mechanical ventilation, and use of inotropes among hospitalized patients.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07517939
Sponsor's protocol ID
AKI in ICU children
Status last verified
Apr 2026
First submitted
2 Apr 2026
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of AKI and ICU, 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 4 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: opening soon, as of the sponsor's last update on 8 Apr 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of acute kidney injury (AKI) associated with sepsis and related clinical risk factors. (time frame: One year). 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 8 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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