About this trial
This project aims to conduct an international, prospective, multicentre, observational study to determine the incidence of Postoperative Acute Kidney Injury (PO-AKI) in hospitalized children after noncardiac surgery. Urinary biomarkers are intended to be evaluated as predictors of PO-AKI in the same subjects. The study employs modern standardized classifications for AKI to comprehensively address the issue of PO-AKI in children. Describing the incidence and identifying risk factors for PO-AKI will play a crucial role in developing preventive strategies aimed at reducing associated mortality and morbidity. Furthermore, investigating the relationship between urinary biomarkers of renal injury and PO-AKI will provide valuable insights into assessing postoperative renal function in paediatric patients, especially when repeated blood sampling is not feasible.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Elective, urgent or emergency in-patient major non-cardiac surgical procedures performed under general anaesthesia with or without regional analgesia with a planned procedure duration of at least 60 minutes.
Paediatric patients (0-16 years old)
Disqualifiers
Declined participation.
Ongoing renal replacement therapy
Acute Kidney Injury (according to KDIGO)
Known chronic kidney disease
Trial population
Hospitalised paediatric patients undergoing major non-cardiac surgery in any of the specified investigator sites
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of postoperative AKI
Incidence of postoperative AKI, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria, based on changes in plasma/serum creatinine concentration from baseline within the postoperative period: * AKI Stage 1: Increase in plasma/serum creatinine ≥ 0.3 mg/dL (26.5 µmol/L) within 48 hours postoperatively OR 1.5-1.9 times baseline plasma/serum creatinine within 7 postoperative days. * AKI Stage 2: Increase in plasma/serum creatinine 2-2.9 times baseline p/s creatinine within 7 postoperative days. * AKI Stage 3: Increase in plasma/serum creatinine \> 3 times baseline plasma/serum creatinine within 7 postoperative days OR increase in plasma/serum creatinine to 4.0mg/dL (353.6 µmol/L) OR Initiation of renal replacement therapy OR decrease in eGFR to \< 35mL/min per 1.73 m2. All within 7 postoperative days. Baseline creatinine is defined as a plasma/serum creatinine value obtained within 24 hours prior of commencement of surgery.
Secondary outcomes
Agreement and association between changes in plasma/serum creatinine and urinary biomarkers of renal injury.
Examples of urinary biomarkers: Neutrophil gelatinase-associated lipocalin (NGAL) Kidney injury molecule-1 (KIM-1) Tissue inhibitor of metalloproteinase 2 (TIMP-2) Insulin-like growth factor binding protein-7 (IGFBP-7) S100 calcium-binding protein A8 (S100A8) Osteoprotegerin (OPG) Galectin 3 Elastase Cystatin C Albumin/Creatinine-ratio
Time from surgery to first AKI-qualifying creatinine
Perioperative risk factors associated with postoperative AKI
Diagnostic accuracy of plasma cystatin C for postoperative AKI and agreement with creatinine-based definitions.
These analyses aim to evaluate how well urinary biomarkers discriminate AKI versus no AKI within the postoperative window. Biomarker distributions will be assessed and skewed biomarkers will be log-transformed as appropriate. Defined rules for values below/above assay limits (LLOQ/ULOQ) will be applied (e.g., imputation at LLOQ/2 for below LLOQ, or use of censored methods if needed) based on approach specified per assay. If urine dilution adjustment is used (e.g., indexing to urine creatinine), both raw and indexed values will be examined and available in main text or in supplement. The primary diagnostic measure will be the area under the receiver operating characteristic curve (AUROC) with 95% CI (e.g., DeLong method). ROC curves will be presented for each biomarker. If clinically meaningful cut-offs are available, sensitivity, specificity, positive/negative predictive values, and likelihood ratios will be reported with 95% CIs. If no established cut-offs exist, an "optimal" cut-of
Other outcomes
Incidence of postoperative dysnatraemia and associated risk factors
Incidence of postoperative dyschloremia and associated risk factors.
Incidence of postoperative dyskalemia and associated risk factors.
Incidence of postoperative AKI defined by urine output
Urine output criteria for AKI will be recorded where available, but creatinine-based KDIGO criteria constitute the primary diagnostic definition. If patient age at time of surgery ≥ 28 days: AKI Stage 1: \<0.5 mL/kg/h for 6-12h AKI Stage 2: \<0.5 mL/kg/h for ≥ 12h AKI Stage 3: \<0.3 mL/kg/h for ≥24h or anuria ≥12h If patient age at time of surgery \< 28 days: AKI Stage 1: \<1 mL/kg/h for ≥24h AKI Stage 2: \<0.5 mL/kg/h for ≥24h AKI Stage 3: \<0.3 mL/kg/h for ≥24h or anuria ≥12h
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Uppsala University
Lead sponsor
Uppsala University Hospital
Collaborator
Karolinska Institutet
Collaborator
Skane University Hospital
Collaborator
Karolinska University Hospital
Collaborator
Istituto Giannina Gaslini
Collaborator
Queen Silvia Children's Hospital, Gothenburg, Sweden
Collaborator
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Collaborator
University of Belgrade
Collaborator
University Hospital, Basel, Switzerland
Collaborator
Hospices Civils de Lyon
Collaborator
University of Bern
Collaborator
University Hospital, Geneva
Collaborator
Child and Adolescent Health Service - Perth
Collaborator
Lund University
Collaborator
University Childrens Hospital Belgrade
Collaborator
Children's Hospital Zagreb
Collaborator
University Children's Hospital Basel
Collaborator
Montreal Children's Hospital of the MUHC
Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Radboud University Medical Center
Collaborator
Tel Aviv Medical Center
Collaborator
Tel Aviv University
Collaborator
University of Geneva, Switzerland
Collaborator
Sahlgrenska University Hospital
Collaborator