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Identifying Risk Factors for Developing AKI in Sepsis

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ClinicalTrials.gov Identifier: NCT04825639
Recruitment Status : Completed
First Posted : April 1, 2021
Last Update Posted : July 22, 2022
Information provided by (Responsible Party):
Cardiff and Vale University Health Board

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.

Condition or disease Intervention/treatment
Sepsis Acute Kidney Injury Diabetic Ketoacidosis 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 7 Days
Official Title: A Retrospective Study to Evaluate the Prevalence of Acute Kidney Injury in Patients With DKA and Sepsis
Actual Study Start Date : March 15, 2021
Actual Primary Completion Date : March 30, 2022
Actual Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment

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

Primary Outcome Measures :
  1. Prevalence of Acute Kidney Injury in the sepsis and DKA cohorts [ Time Frame: 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)

Secondary Outcome Measures :
  1. Risk factors associated with AKI [ Time Frame: 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.

  2. Compare chloride levels in the AKI and non AKI groups [ Time Frame: during admission in PICU ]
    The units used for Chloride levels is mMol/Litre

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Ages Eligible for Study:   0 Days to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04825639

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United Kingdom
Noah's Ark Children's hospital
Cardiff, South Glamorgan, United Kingdom, CF14 4XW
Sponsors and Collaborators
Cardiff and Vale University Health Board
Publications of Results:
Other 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

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Responsible Party: Cardiff and Vale University Health Board
ClinicalTrials.gov Identifier: NCT04825639    
Other Study ID Numbers: 20/DEC/8064
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Diabetic Ketoacidosis
Systemic Inflammatory Response Syndrome
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Acid-Base Imbalance
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases