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Goal-directed perfusion to reduce acute kidney injury after paediatric cardiac surgery (GDP-AKIp): study protocol for
Yan Zhang1, Xiujuan Zhou1, Bo Wang1
1Anesthesiology, West China Hospital of Sichuan University, Chengdu, China.
Insights
This study investigates if a goal-directed perfusion (GDP) strategy, maintaining indexed oxygen delivery (DO2i) at or above 360 mL/min/m2 during pediatric cardiac surgery, can reduce acute kidney injury (AKI). The findings aim to improve outcomes for children undergoing cardiac procedures.
Area of Science:
- Cardiology
- Nephrology
- Pediatric Surgery
Background:
- Cardiac surgery-associated acute kidney injury (CS-AKI) affects 40-60% of pediatric patients, increasing morbidity and mortality.
- A goal-directed perfusion (GDP) strategy, targeting indexed oxygen delivery (DO2i) above 260-300 mL/min/m2 during cardiopulmonary bypass (CPB), is known to reduce CS-AKI in adults.
- Previous research identified a nadir DO2i <353 mL/min/m2 as an independent risk predictor for CS-AKI in pediatric CPB.
Purpose of the Study:
- To determine if implementing a GDP strategy, aiming for DO2i ≥360 mL/min/m2, reduces CS-AKI rates in pediatric patients undergoing cardiac surgery.
- To evaluate the impact of this GDP strategy on other clinical outcomes, including complications and mortality.
Main Methods:
- A prospective, single-centre, randomized controlled trial involving 166 pediatric patients undergoing cardiac surgery.
- Patients are randomized into two groups: GDP arm (DO2i ≥360 mL/min/m2) and control arm (perfusion based on body surface area and temperature).
- Primary outcome is the rate of postoperative CS-AKI, defined by pediatric RIFLE criteria. Secondary outcomes include oxygen metabolism, complications, mortality, and short-term clinical outcomes.
Main Results:
- This section is to be filled once the study is completed and results are available.
Conclusions:
- This section is to be filled once the study is completed and results are available.
Introduction:
Cardiac surgery-associated acute kidney injury (CS-AKI) occurs in up to 40%~60% of paediatric patients and increases postoperative morbidity and mortality. A goal-directed perfusion (GDP) strategy aimed at maintaining indexed oxygen delivery (DO2i) above the critical threshold (reported to be 260~300 mL/min/m2 in adults) during cardiopulmonary bypass (CPB), is effective in reducing the incidence of CS-AKI. However, no clear standards of paediatric critical DO2i exist. Our prior prospective cohort study exploring the critical DO2i threshold during paediatric CPB has found the nadir DO2i <353 mL/min/m2 was an independent risk predictor of CS-AKI. Based on this background, this trial is designed to further determine whether the implementation of the GDP initiative aimed at maintaining DO2i ≥360 mL/min/m2 would reduce the rate of CS-AKI in paediatrics and improve clinical outcome.
Methods And Analysis:
This is a prospective, single-centre, randomised controlled trial. In total, 166 paediatric patients undergoing cardiac surgery will be randomly allocated to the GDP group or control group. Patients in the GDP arm will be treated with a GDP strategy during CPB aimed to maintain DO2i at ≥360 mL/min/m2 (to ensure safely above the risk DO2i threshold we found). The perfusion strategy for patients in the control arm will be factored on body surface area and temperature. The primary outcome is the rate of postoperative CS-AKI (it is defined according to paediatric Risk, Injury, Failure, Loss of renal function and End-stage renal disease criteria). The secondary end points include: (1) the other oxygen metabolism parameters during CPB; (2) major complication and all-cause mortality (in-hospital or within 30 days postoperatively); (3) short-term clinical outcomes (ie, time to extubation, mechanical ventilation time, hospital stay).
Ethics And Dissemination:
The study has been approved by the Biomedical Research Ethics committee of West China Hospital of Sichuan University (approval number: 2019(863)). Results will be disseminated through peer-reviewed publications and conferences.
Trial Registration Number:
ChiCTR2000029232.
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