Identifying Risk Factors for Developing AKI in Sepsis

NCT ID: NCT04825639

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2022-03-31

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.

Conditions

Sepsis; Acute Kidney Injury; Diabetic Ketoacidosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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)

No intervention

Intervention Type: OTHER

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.

No intervention

Intervention Type: OTHER

no intervention

Interventions

No intervention

no intervention

Intervention Type: OTHER

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)

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiff and Vale University Health Board

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Noah's Ark Children's hospital

Cardiff, South Glamorgan, United Kingdom

Countries

United Kingdom

References

2. Link to the guidelines documents accessed on 29/03/3-21:https://www.bsped.org.uk/media/1798/bsped-dka-guideline-2020.pdf

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: RESULT

PMID: 15636651 (View on PubMed)

Other Identifiers

20/DEC/8064

Identifier Type: -

Identifier Source: org_study_id