Postoperative Acute Kidney Injury in Children Undergoing Major Non-cardiac Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-16
SponsorUppsala University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: Children undergoing major non-cardiac surgery under general anaesthesia

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 7 postoperative days

Secondary outcomes

1

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 frame
Within 7 postoperative days
2

Time from surgery to first AKI-qualifying creatinine

Time frame
Within 7 postoperative days
3

Perioperative risk factors associated with postoperative AKI

Time frame
Within 7 postoperative days
4

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

Time frame
Within 7 postopertive days

Other outcomes

1

Incidence of postoperative dysnatraemia and associated risk factors

Time frame
Within 7 postoperative days
2

Incidence of postoperative dyschloremia and associated risk factors.

Time frame
Within 7 postoperative days
3

Incidence of postoperative dyskalemia and associated risk factors.

Time frame
Within 7 postoperative days
4

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

Time frame
Within 3 postoperative days

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