Postoperative acute kidney injury in children after major non-cardiac surgery
An International Multicentre Prospective Study of Postoperative Acute Kidney Injury in Hospitalized Paediatric Patients
This international observational study will test whether urinary biomarkers can help predict postoperative acute kidney injury in hospitalized children (0–16 years) undergoing major non-cardiac surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 0 Years to 16 Years |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Locations | 13 sites (Perth, Western Australia and 12 other locations) |
| Trial ID | NCT07351149 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 0–16 hospitalized for elective, urgent, or emergency major non-cardiac surgery under general anaesthesia with planned duration ≥60 minutes and without pre-existing kidney disease or ongoing renal replacement therapy are ideal candidates.
Not a fit: Children already receiving renal replacement therapy, with existing AKI or chronic kidney disease, undergoing kidney surgery or procedures with kidney blood-flow clamping or contrast administration, or weighing under 2 kg are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, the findings could enable earlier, noninvasive detection of postoperative AKI and guide prevention to reduce morbidity and mortality in children.
How similar studies have performed: Adult PO-AKI research has shown urinary biomarkers can predict kidney injury, but equivalent large prospective multicentre pediatric data for noncardiac surgery are limited, so this approach is relatively novel in children.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Perth, Western Australia and 12 other locations
- Perth Children's Hospital — Perth, Western Australia, Australia (Not_yet_recruiting)
- The Kids Research Institute Australia — Perth, Western Australia, 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.