Clinical trial NCT04825639: Identifying Risk Factors for Developing AKI in Sepsis
Official title: A Retrospective Study to Evaluate the Prevalence of Acute Kidney Injury in Patients With DKA and Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Acute Kidney Injury
Diabetic Ketoacidosis
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
First posted: 2021-04-01
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Acute Kidney Injury in the sepsis and DKA cohorts
timeFrame: during admission to PICU
Secondary outcomes:
measure: Risk factors associated with AKI
timeFrame: During admission to PICU
measure: Compare chloride levels in the AKI and non AKI groups
timeFrame: during admission in PICU
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Noah's Ark Children's hospital
state: South Glamorgan
Study officials:
References:
citation: 2. Link to the guidelines documents accessed on 29/03/3-21:https://www.bsped.org.uk/media/1798/bsped-dka-guideline-2020.pdf
citation: 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
citation: 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.