Identifying Risk Factors for Developing AKI in Sepsis

NCT04825639 | Completed

• 1 other identifier: 20/DEC/8064
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Acute Kidney Injury; Diabetic Ketoacidosis

Outcome Measures

Primary Outcomes (1)

• Prevalence of Acute Kidney Injury in the sepsis and DKA cohorts

  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)

  during admission to PICU

Secondary Outcomes (2)

• Risk factors associated with AKI

  During admission to PICU

• Compare chloride levels in the AKI and non AKI groups

  during admission in PICU

Study Arms (2)

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)

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.

Other: No intervention

Interventions

No intervention OTHER

no intervention

Diabetic Ketoacidosis (DKA); Sepsis

Eligibility Criteria

• Age: 0 Days - 18 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Noah's Ark Children's hospital

Cardiff, South Glamorgan, CF14 4XW, United Kingdom

Location

Related Publications (3)

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

  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

  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.

  PMID: 15636651 RESULT

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury; Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 7 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: March 15, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 31, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)