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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Acute Kidney Injury; Diabetic Ketoacidosis
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United Kingdom
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF14 4XW
      • Noah's Ark Children's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: No intervention; no intervention
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.	Other: No intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Acute Kidney Injury in the sepsis and DKA cohorts	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors associated with AKI	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	The units used for Chloride levels is mMol/Litre	during admission in PICU

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board

Publications and helpful links

General Publications

• 2. Link to the guidelines documents accessed on 29/03/3-21:https://www.bsped.org.uk/media/1798/bsped-dka-guideline-2020.pdf
• Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline for acute kidney injury.Kidney Int Suppl. 2012;2:1-141. doi: 10.1038/kisup.2012.3
• Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Infections; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Renal Insufficiency; Acid-Base Imbalance; Acidosis; Sepsis; Toxemia; Acute Kidney Injury; Ketosis; Diabetic Ketoacidosis
• Other Study ID Numbers: 20/DEC/8064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No