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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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South Glamorgan
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Cardiff, South Glamorgan, Reino Unido, CF14 4XW
- Noah's Ark Children's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Otro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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) |
Sin intervención
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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. |
Sin intervención
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Prevalence of Acute Kidney Injury in the sepsis and DKA cohorts
Periodo de tiempo: during admission to PICU
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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)
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during admission to PICU
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Risk factors associated with AKI
Periodo de tiempo: During admission to PICU
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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.
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During admission to PICU
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Compare chloride levels in the AKI and non AKI groups
Periodo de tiempo: during admission in PICU
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The units used for Chloride levels is mMol/Litre
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during admission in PICU
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Infecciones
- Enfermedades Renales
- Enfermedades urológicas
- Síndrome de Respuesta Inflamatoria Sistémica
- Inflamación
- Enfermedades del sistema endocrino
- Complicaciones de la diabetes
- Diabetes mellitus
- Insuficiencia renal
- Desequilibrio ácido-base
- Acidosis
- Septicemia
- Toxemia
- Lesión renal aguda
- Cetosis
- Cetoacidosis diabética
Otros números de identificación del estudio
- 20/DEC/8064
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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