Postoperative acute kidney injury in children after major non-cardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicentre, observational study enrolling hospitalized children aged 0–16 who undergo major non-cardiac surgery lasting at least 60 minutes. The study will determine the incidence and risk factors for postoperative acute kidney injury (PO-AKI) using standardized KDIGO classifications and will collect urine samples to measure candidate renal injury biomarkers. Patients will be followed perioperatively with records of creatinine, urine output, and clinical outcomes without changing standard care. The aim is to see if urinary biomarkers can predict PO-AKI when repeated blood sampling is impractical and to inform future prevention strategies.

Why it matters

Who can join: the full rules

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)

Where it's running

• Hospital das Clínicas HCFMUSP
  São Paulo, Brazil Recruiting
• IRCCS Istituto Giannina Gaslini
  Genova, Italy Recruiting
• University Hospital of Belgrade
  Belgrade, Serbia Recruiting
• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Karolinska University Hospital
  Stockholm, Sweden Recruiting
• Uppsala University Hospital
  Uppsala, Sweden Recruiting

Study contacts

• Principal investigator: Robert Frithiof, MD, PhD — Uppsala University Hospital, Uppsala, Sweden
• Study coordinator: Robert Frithiof, Md, PhD
• Email: robert.frithiof@uu.se
• Phone: +46-72-2406252

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.