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

NCT07351149 | Recruiting

• 1 other identifier: POAKIDS-2025-04168-02
• Study Type: observational
• Target: 2,000
• Locations: 6 countries
• Sites: 12

Brief 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.

Conditions

Acute Kidney Injury

Keywords

Postoperative acute kidney injury; Pediatric kidney injury; Pediatric renal failure; Urinary biomarkers; Pediatric urinary biomarkers; Pediatric postoperative kidney injury; Pediatric anesthesia; Risk factors for pediatric acute kidney injury

Outcome Measures

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.

  Within 7 postoperative days

Secondary Outcomes (5)

• Agreement and association between changes in plasma/serum creatinine and urinary biomarkers of renal injury.

  Within 7 postoperative days

• Time from surgery to first AKI-qualifying creatinine

  Within 7 postoperative days

• Perioperative risk factors associated with postoperative AKI

  Within 7 postoperative days

• Diagnostic accuracy of plasma cystatin C for postoperative AKI and agreement with creatinine-based definitions.

  Within 7 postopertive days

• Associations between AKI and mortality, length of stay and renal replacement therapy

  Within 7 postoperative days

Other Outcomes (5)

• Incidence of postoperative dysnatraemia and associated risk factors

  Within 7 postoperative days

• Incidence of postoperative dyschloremia and associated risk factors.

  Within 7 postoperative days

• Incidence of postoperative dyskalemia and associated risk factors.

  Within 7 postoperative days

Study Arms (1)

Children undergoing major non-cardiac surgery under general anaesthesia

Eligible participants are children aged 0-16 years admitted for non-ambulatory, non-cardiac major surgery requiring general anaesthesia with an estimated duration of at least 60 minutes, including elective, urgent, and emergency procedures. Non-ambulatory surgery is defined as a planned overnight hospital admission following the procedure.

Eligibility Criteria

• Age: 0 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalised paediatric patients undergoing major non-cardiac surgery in any of the specified investigator sites

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator
• Karolinska Institutet: collaborator
• Skane University Hospital: collaborator
• Karolinska University Hospital: collaborator
• Queen Silvia Children's Hospital, Gothenburg, Sweden: collaborator
• Feculdade de Medicina da Universidade de Sao Paulo - Brasil: 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
• Istituto Giannina Gaslini: collaborator
• University of Belgrade: collaborator

Study Sites (13)

Perth Children's Hospital

Perth, Western Australia, 6909, Australia

NOT YET RECRUITING

The Kids Research Institute Australia

Perth, Western Australia, 6909, 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

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Urine Blood

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Robert Frithiof, MD, PhD

  Uppsala University Hospital, Uppsala, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Frithiof, Md, PhD

CONTACT

+46-72-2406252; robert.frithiof@uu.se

Arash Emami, MD

CONTACT

arash.emami@uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 12 months after publication of the primary results and will remain available upon reasonable request for at least 5 years thereafter.
• Access Criteria: Access to the de-identified dataset will be granted to qualified researchers upon reasonable request. Requests must include a brief description of the research question, analysis plan, and intended use of the data. All requests will be reviewed by the POAKIDS steering committee. Data will be shared only for scientifically sound projects and for purposes consistent with the original study objectives and ethical approvals. Data will be shared through secure data transfer following approval of a data sharing agreement. No direct identifiers or site-specific identifiers will be included in the shared dataset.

Locations

CH (3); IT (1); BR (1); AU (2); FR (1); SE (4)