Skip to main content
Clinical Trials/NCT07351149
NCT07351149RecruitingNot Applicable

An International Multicentre Prospective Study of Postoperative Acute Kidney Injury in Hospitalized Paediatric Patients

Uppsala University13 sites in 7 countries2,000 target enrollmentStarted: March 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
2,000
Locations
13
Primary Endpoint
Incidence of postoperative AKI

Study Overview

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.

Detailed Description

INTRODUCTION Acute Kidney Injury refers to a sudden impairment in renal function, reflected by increased plasma creatinine concentration and/or decreased urine output. Traditionally, only the most severe reduction in renal function with azotemia and anuria has been emphasised as significantly deleterious, but during the last decades evidence suggests that acute, relatively mild or moderate injury to the kidney portend serious clinical consequences. In critical illness, AKI is strongly associated with short-term mortality as well as chronic kidney disease, cardiovascular disease, and premature death, even when kidney function has recovered.

PO-AKI is characterized by a sudden and significant decline in renal function after surgery. In adults, it is established that PO-AKI is common, imposes a heavy burden of illness, is amenable to early detection and potential prevention and infers a high cost per person in management. There is also considerable variability in practice to prevent, diagnose, treat and achieve outcomes of AKI. Detailed knowledge of incidence rates, risk factors, and outcomes of PO-AKI have considerably enhanced our understanding of optimal treatment and prevention strategies.

Compared to the adult population, there remains a paucity of research data pertaining to PO-AKI for noncardiac surgery in children. However, there is a rational presumption that identifying, preventing, and treating a condition like PO-AKI, which carries enduring long-term consequences, would be particularly advantageous in paediatric patients. The known high burden of AKI in children who are critically ill or undergoing cardiac surgery underscore the importance of accurately and prospectively describing incidence and risk factors for paediatric PO-AKI.

Contemporary evidence advocates for the utilization of innovative urinary biomarkers in predicting and managing AKI. Nevertheless, additional studies are imperative to advance scientific and clinical comprehension regarding the optimal methods and timing for their application, not the least in the perioperative setting. The clinical promise of these biomarkers is particularly pronounced in paediatric populations due to the considerable impediment posed by the necessity for frequent blood sampling in diagnosing and staging PO-AKI within this group. Further investigation stands to enhance the understanding and implementation of these biomarkers, offering substantial potential benefits in the management of paediatric PO-AKI. However, data regarding PO-AKI in paediatric patients, especially those undergoing noncardiac surgery, are notably limited.

RESEARCH QUESTIONS

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
0 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

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.

Outcomes

Primary Outcomes

Incidence of postoperative AKI

Time Frame: 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.

Secondary Outcomes

  • Time from surgery to first AKI-qualifying creatinine(Within 7 postoperative days)
  • Perioperative risk factors associated with postoperative AKI(Within 7 postoperative days)
  • Associations between AKI and mortality, length of stay and renal replacement therapy(Within 7 postoperative days)
  • Agreement and association between changes in plasma/serum creatinine and urinary biomarkers of renal injury.(Within 7 postoperative days)
  • Diagnostic accuracy of plasma cystatin C for postoperative AKI and agreement with creatinine-based definitions.(Within 7 postopertive days)

Investigators

Sponsor
Uppsala University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (13)

Loading locations...

Similar Trials