NCT04825639

Identifying Risk Factors for Developing AKI in Sepsis

A Retrospective Study to Evaluate the Prevalence of Acute Kidney Injury in Patients With DKA and Sepsis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Cardiff and Vale University Health Board · Other Government
• Sex: All
• Age: 0 Days – 18 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the prevalence of Acute Kidney Injury (AKI) in patients with Diabetic Ketoacidosis (DKA) and sepsis using data collected prospectively to a patient registry. The primary objective is to compare the prevalence of AKI in sepsis and DKA in different age groups in children and investigate the difference in the prevalence of hyperchloremia in the two groups.Secondary objectives are Compare the prevalence of AKI in sepsis and DKA in different age groups in children and investigate the difference in the prevalence of hyperchloremia in the two groups.

Detailed description

It is a descriptive study to report the prevalence ofAcute Kidney Injury ( AKI) in the two cohorts of sepsis and Diabetic Ketoacidosis ( DKA). In addition we aim to evaluate the relation with hyperchloremia. In both groups, attempts will be made to evaluate the association of risk factors such as severity of dehydration/shock and hyperchloremia with AKI in the two groups. Data will be analysed using SPSS software. Categorical variables will be analysed using Chi-square test and if appropriate, multiple logistic regression analysis. Continuous variable will be analysed with Student's T test and if possible, by linear regression modelling. The differences between the two groups may analysed using Analysis of Variance (ANOVA). The study will collect anonymous data from 2015 to 2020 from the Paediatric Intensive Care Audit Network (PICANet) database for a tertiary PICU servicing the pediatric population of Wales.This data is submitted prospectively for audit of clinical outcomes of children admitted for paediatric intensive care in the United Kingdom. The study was reviewed by the Institutional Research and Development department and was given exemption for ethics committee review as it does not involve direct patient contact and the data is anonymous. Approval was obtained from the relevant database manager, institutional information governance department as well as the Health Care Research Wales.

Conditions

• Sepsis
• Acute Kidney Injury
• Diabetic Ketoacidosis

Interventions

Type	Name	Description
OTHER	No intervention	no intervention

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-03-30
• Completion: 2022-03-31
• First posted: 2021-04-01
• Last updated: 2022-07-22

Locations

1 site across 1 country: United Kingdom