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

NCT07351149 · tracked via the Priya Life Science Brazil tracker

Sponsor

Uppsala University

Phase

Observational

Started

2026-03-01

Last updated

2026-05-12

Condition(s) studied

Acute Kidney Injury

Study summary

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

Sex

ALL

Min age

0 Years

Max age

16 Years

Healthy volunteers

Inclusion Criteria: * 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) Exclusion Criteria: * Declined participation. * Ongoing renal replacement therapy * Acute Kidney Injury (according to KDIGO) * Known chronic kidney disease * Procedure involving surgery of the kidney * Procedures requiring clamping of blood flow to or from the kidney * Body weight \<2kg * Procedure involving contrast administration * Established rhabdomyolysis (CK-levels \>1500 U/L)

Primary outcome measure(s)

Incidence of postoperative AKI — Within 7 postoperative days
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.

Trial sites (13)

Facility	City	Region	Status
Perth Children's Hospital	Perth	Western Australia	Not Yet Recruiting
The Kids Research Institute Australia	Perth	Western Australia	Not Yet Recruiting
Hospital das Clínicas HCFMUSP	São Paulo	Brazil	Not Yet Recruiting
Hospices Civils de Lyon	Lyon	France	Not Yet Recruiting
IRCCS Istituto Giannina Gaslini	Genova	Italy	Not Yet Recruiting
University Hospital of Belgrade	Belgrade	Serbia	Not Yet Recruiting
Sahlgrenska University Hospital	Gothenburg	Sweden	Not Yet Recruiting
Skåne University Hospital	Lund	Sweden	Not Yet Recruiting
Karolinska University Hospital	Stockholm	Sweden	Recruiting
Uppsala University Hospital	Uppsala	Sweden	Recruiting
University Hospital Basel	Basel	Switzerland	Not Yet Recruiting
University Hospital Bern	Bern	Switzerland	Not Yet Recruiting
University Hospital Geneva	Geneva	Switzerland	Not Yet Recruiting

More Uppsala University trials in Brazil

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07351149 on ClinicalTrials.gov ↗ ← All trials in Brazil