Predictors of Acute Kidney Injury in Critically Ill Children Admitted to PICU.

Acute Kidney Injury Clinical Trial

Official title:

Predictors of Acute Kidney Injury in Critically Ill Children Admitted to Pediatrics Intensive Care Unit At Assiut University Children Hospital.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06328478
• Other study ID #: Predictors of AKI in PICU.
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: Martina Adel Labib
• Phone: 01283047091
• Email: martina.adel265[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2025
• Est. primary completion date: April 1, 2025
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Device:
• Observational prospective study.
Observational prospective study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute kidney injury and survival to discharge from the PICU.		One year from April 2024 to May 2025