Acute Kidney InjuryNCT06328478
Predictors of Acute Kidney Injury in Critically Ill Children Admitted to PICU.
An observational study of Acute Kidney Injury, run by Assiut University.
Trial summary
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
- Acute Kidney Injury
- What is being tested?
- Observational prospective study.
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Child, Adult
Study population: All cases of acute kidney injury in pediatrics from 1 month to 18 years incritically ill Patient admitted to PICU Assiut University Children Hospital during one year of the study.
Who may be able to join
- children aged from month to 18 years admitted to PICU between April 2024 to May 2025.
Who cannot join
- Exclusion of children aged below 1 month and older than 18 years.
- chronic kidney disease.
- renal malformations.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Predictors of Acute Kidney Injury in Critically Ill Children Admitted to Pediatrics Intensive Care Unit At Assiut University Children Hospital.
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 (CKD).
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 >3 months 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. 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
- Acute Kidney Injury
- Being tested
- Observational prospective study.
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational prospective study.Device
Observational prospective study
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury and survival to discharge from the PICU.
Measured: One year from April 2024 to May 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Adel Labib Attia, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328478
- Sponsor's protocol ID
- Predictors of AKI in PICU.
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kellum JA, Romagnani P, Ashuntantang G, Ronco C, Zarbock A, Anders HJ. Acute kidney injury. Nat Rev Dis Primers. 2021 Jul 15;7(1):52. doi: 10.1038/s41572-021-00284-z.
PubMed 34267223Basu RK, Kaddourah A, Terrell T, Mottes T, Arnold P, Jacobs J, Andringa J, Goldstein SL; Prospective Pediatric AKI Research Group (ppAKI). Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in critically ill children (AWARE): study protocol for a prospective observational study. BMC Nephrol. 2015 Feb 26;16:24. doi: 10.1186/s12882-015-0016-6.
PubMed 25882434Ciccia E, Devarajan P. Pediatric acute kidney injury: prevalence, impact and management challenges. Int J Nephrol Renovasc Dis. 2017 Mar 29;10:77-84. doi: 10.2147/IJNRD.S103785. eCollection 2017.
PubMed 28435306Naik S, Sharma J, Yengkom R, Kalrao V, Mulay A. Acute kidney injury in critically ill children: Risk factors and outcomes. Indian J Crit Care Med. 2014 Mar;18(3):129-33. doi: 10.4103/0972-5229.128701.
PubMed 24701061Duzova A, Bakkaloglu A, Kalyoncu M, Poyrazoglu H, Delibas A, Ozkaya O, Peru H, Alpay H, Soylemezoglu O, Gur-Guven A, Bak M, Bircan Z, Cengiz N, Akil I, Ozcakar B, Uncu N, Karabay-Bayazit A, Sonmez F; Turkish Society for Pediatric Nephrology Acute Kidney Injury Study Group. Etiology and outcome of acute kidney injury in children. Pediatr Nephrol. 2010 Aug;25(8):1453-61. doi: 10.1007/s00467-010-1541-y. Epub 2010 May 30.
PubMed 20512652Cleto-Yamane TL, Gomes CLR, Suassuna JHR, Nogueira PK. Acute Kidney Injury Epidemiology in pediatrics. J Bras Nefrol. 2019 Apr-Jun;41(2):275-283. doi: 10.1590/2175-8239-JBN-2018-0127. Epub 2018 Nov 14.
PubMed 30465591Uber AM, Sutherland SM. Acute kidney injury in hospitalized children: consequences and outcomes. Pediatr Nephrol. 2020 Feb;35(2):213-220. doi: 10.1007/s00467-018-4128-7. Epub 2018 Nov 1.
PubMed 30386936
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Acute Kidney Injury in Critically Ill Children Admitted to Pediatrics Intensive Care Unit At Assiut University Children Hospital.
- ClinicalTrials.gov ID
- NCT06328478
- Acronym / sponsor ID
- Predictors of AKI in PICU.
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 25 Mar 2024 (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.
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 (CKD).
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 >3 months 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. 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
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All cases of acute kidney injury in pediatrics from 1 month to 18 years incritically ill Patient admitted to PICU Assiut University Children Hospital during one year of the study.
Key inclusion criteria (1 listed)
- children aged from month to 18 years admitted to PICU between April 2024 to May 2025.
Key exclusion criteria (3 listed)
- Exclusion of children aged below 1 month and older than 18 years.
- chronic kidney disease.
- 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 |
|---|---|---|
| Observational prospective study.Observational prospective study | Device | – |
Primary outcome
Incidence of acute kidney injury and survival to discharge from the PICU.
Time frame: One year from April 2024 to May 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 34267223Kellum JA, Romagnani P, Ashuntantang G, Ronco C, Zarbock A, Anders HJ. Acute kidney injury. Nat Rev Dis Primers. 2021 Jul 15;7(1):52. doi: 10.1038/s41572-021-00284-z.
- Background: PubMed 25882434Basu RK, Kaddourah A, Terrell T, Mottes T, Arnold P, Jacobs J, Andringa J, Goldstein SL; Prospective Pediatric AKI Research Group (ppAKI). Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in critically ill children (AWARE): study protocol for a prospective observational study. BMC Nephrol. 2015 Feb 26;16:24. doi: 10.1186/s12882-015-0016-6.
- Background: PubMed 28435306Ciccia E, Devarajan P. Pediatric acute kidney injury: prevalence, impact and management challenges. Int J Nephrol Renovasc Dis. 2017 Mar 29;10:77-84. doi: 10.2147/IJNRD.S103785. eCollection 2017.
- Background: PubMed 24701061Naik S, Sharma J, Yengkom R, Kalrao V, Mulay A. Acute kidney injury in critically ill children: Risk factors and outcomes. Indian J Crit Care Med. 2014 Mar;18(3):129-33. doi: 10.4103/0972-5229.128701.
- Background: PubMed 20512652Duzova A, Bakkaloglu A, Kalyoncu M, Poyrazoglu H, Delibas A, Ozkaya O, Peru H, Alpay H, Soylemezoglu O, Gur-Guven A, Bak M, Bircan Z, Cengiz N, Akil I, Ozcakar B, Uncu N, Karabay-Bayazit A, Sonmez F; Turkish Society for Pediatric Nephrology Acute Kidney Injury Study Group. Etiology and outcome of acute kidney injury in children. Pediatr Nephrol. 2010 Aug;25(8):1453-61. doi: 10.1007/s00467-010-1541-y. Epub 2010 May 30.
- Background: PubMed 30465591Cleto-Yamane TL, Gomes CLR, Suassuna JHR, Nogueira PK. Acute Kidney Injury Epidemiology in pediatrics. J Bras Nefrol. 2019 Apr-Jun;41(2):275-283. doi: 10.1590/2175-8239-JBN-2018-0127. Epub 2018 Nov 14.
- Background: PubMed 30386936Uber AM, Sutherland SM. Acute kidney injury in hospitalized children: consequences and outcomes. Pediatr Nephrol. 2020 Feb;35(2):213-220. doi: 10.1007/s00467-018-4128-7. Epub 2018 Nov 1.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, 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 3 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Adel Labib (01283047091, martina.adel265@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury and survival to discharge from the PICU. (time frame: One year from April 2024 to May 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06328478, which also lists 7 linked publications.
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 16 Apr 2024.