- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06328478
Predictors of Acute Kidney Injury in Critically Ill Children Admitted to PICU.
Predictors of Acute Kidney Injury in Critically Ill Children Admitted to Pediatrics Intensive Care Unit At Assiut University Children Hospital.
Study Overview
Status
Conditions
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 (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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Martina Adel Labib
- Phone Number: 01283047091
- Email: martina.adel265@gmail.com
Study Contact Backup
- Name: Ismail Lotfy Mohamad
- Phone Number: 01063398967
- Email: ismail231@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- children aged from month to 18 years admitted to PICU between April 2024 to May 2025.
Exclusion Criteria:
- Exclusion of children aged below 1 month and older than 18 years.
- chronic kidney disease.
- renal malformations.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of acute kidney injury and survival to discharge from the PICU.
Time Frame: One year from April 2024 to May 2025
|
One year from April 2024 to May 2025
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Basu 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.
- Ciccia 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.
- Naik 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.
- Duzova 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.
- Cleto-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.
- Uber 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Predictors of AKI in PICU.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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