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临床试验/NCT04825639
NCT04825639已完成不适用

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

Cardiff and Vale University Health Board1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Prevalence of Acute Kidney Injury in the sepsis and DKA cohorts

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
0 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Prevalence of Acute Kidney Injury in the sepsis and DKA cohorts

时间窗: during admission to PICU

Acute Kidney Injury will be defined based on the Kidney Disease Improving Global Outcomes (KDIGO) 2012 \[citation 3\] guidelines. Serum Creatinine and Urine output will be used for defining Acute Kidney Injury. Serum creatinine is measured in microMol/litre and urine output in millilitres (ml)

次要结局

  • Compare chloride levels in the AKI and non AKI groups(during admission in PICU)
  • Risk factors associated with AKI(During admission to PICU)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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