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Identifying Risk Factors for Developing AKI in Sepsis

2022年7月21日 更新者:Cardiff and Vale University Health Board

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

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • South Glamorgan
      • Cardiff、South Glamorgan、英国、CF14 4XW
        • Noah's Ark Children's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1秒 至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Children admitted to PICU with sepsis as per the sepsis consensus conference (2005) definition.

Children with DKA admitted to PICU and wards. Diabetic Ketoacidosis defined based on the British Paediatric Society of Endocrinology and Diabetes.

描述

Inclusion Criteria

  • Children under 16 years and admitted to PCCU or wards in the past 5 years
  • Diagnosis of DKA or Sepsis/severe bacterial infection/septic shock

DKA - defined as per the British Society for Paediatric Endocrinology and Diabetes (BSPED) guidance. Sepsis is defined based on the International Pediatric Sepsis Consensus Conference guidance (2005)

8.3. Exclusion Criteria

  • Any patients identified as above but not able to obtain case notes for any reason.
  • Patients with pre-existing kidney conditions
  • Patients with inborn errors of metabolism

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:其他

队列和干预

团体/队列
干预/治疗
Sepsis

Patients admitted to PICU who are selected from registry based on primary diagnoses with codes for the following search codes were selected:

Sepsis is defined as per the International Consensus Conference pediatric sepsis definition (2005) [citation 1].

In silico analysis will be carried out in the sepsis cohort comparing admissions with Acute Kidney Injury (AKI) and those without AKI to identify factors associated with AKI.

In those selected admissions to PICU, information on Renal Function, Chloride levels, clinical outcome and medication use as well as fluid resuscitation will be collected from hospital online resources such as discharge summaries, results portal and the PICANet database. In addition the Paediatric Index of Mortality 3 severity of illness scores will be reported for all admissions.

Sepsis will be defined based on the International Pediatric Consensus Conference definition of sepsis (2005)

没有干预
Diabetic Ketoacidosis (DKA)

This group is defined based on the British Society of Paediatric Endocrinology and Diabetes.case definition for Diabetic Ketoacidosis [citation 2].

The data collected will be similar to the sepsis cohort. In silico analysis will be carried comparing those with AKI and without AKI in the DKA cohort.

没有干预

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Prevalence of Acute Kidney Injury in the sepsis and DKA cohorts
大体时间: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)
during admission to PICU

次要结果测量

结果测量
措施说明
大体时间
Risk factors associated with AKI
大体时间:During admission to PICU
Various risk factors will be evaluated such as cardiac arrest prior to admission or during admission, mechanical ventilation, hypotension or shock requiring vaso-active medications as well as use of medications which may be nephrotoxic.
During admission to PICU
Compare chloride levels in the AKI and non AKI groups
大体时间:during admission in PICU
The units used for Chloride levels is mMol/Litre
during admission in PICU

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月15日

初级完成 (实际的)

2022年3月30日

研究完成 (实际的)

2022年3月31日

研究注册日期

首次提交

2021年3月26日

首先提交符合 QC 标准的

2021年3月30日

首次发布 (实际的)

2021年4月1日

研究记录更新

最后更新发布 (实际的)

2022年7月22日

上次提交的符合 QC 标准的更新

2022年7月21日

最后验证

2022年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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