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.
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
- 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).
- 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.
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.
- First posted8 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKIStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salama Salah, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Acute Kidneyinjury in Children Admitted to Pediatrics Intensive Care Unit at Assiut University ChildrenHospital
- ClinicalTrials.gov ID
- NCT07517939
- Acronym / sponsor ID
- AKI in ICU children
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identify the Predictors of Acute Kidney Injury in critically ill children admitted to PICU during one year
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- acute kidney injury in pediatrics from 1 month to 18years
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Neonates
- patients above 18 years of age
- patients with chronic kidney disease
- patients with renal malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and laboratory assessmentClinical 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. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
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.