Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04825639
Enrollment
300
Registered
2021-04-01
Start date
2021-03-15
Completion date
2022-03-31
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Diabetic Ketoacidosis, Sepsis

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.

Interventions

OTHERNo intervention

no intervention

Sponsors

Cardiff and Vale University Health Board
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
0 Days to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Acute Kidney Injury in the sepsis and DKA cohortsduring admission to PICUAcute 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)

Secondary

MeasureTime frameDescription
Risk factors associated with AKIDuring admission to PICUVarious 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.
Compare chloride levels in the AKI and non AKI groupsduring admission in PICUThe units used for Chloride levels is mMol/Litre

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026