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High-exchange ULTrafiltration to enhance recovery after paediatric cardiac surgery (ULTRA): study protocol for a
Joel Bierer1, Roger Stanzel2, Mark Henderson2
1Division of Cardiac Surgery, Dalhousie University, Halifax, Nova Scotia, Canada Joel.Bierer@nshealth.ca.
Insights
High-exchange subzero-balance ultrafiltration (H-SBUF) may reduce inflammation in pediatric cardiac surgery. This randomized trial compares H-SBUF to low-exchange SBUF (L-SBUF) to assess anti-inflammatory effects and clinical outcomes in children undergoing cardiopulmonary bypass.
Area of Science:
- Pediatric Cardiac Surgery
- Cardiopulmonary Bypass
- Inflammatory Response
Background:
- Congenital heart disease repair often requires cardiopulmonary bypass (CPB), which triggers systemic inflammation.
- CPB-induced inflammation can lead to organ dysfunction, complications, and prolonged recovery in pediatric patients.
- Subzero-balance ultrafiltration (SBUF) is known to remove pro-inflammatory cytokines during CPB.
Purpose of the Study:
- To investigate if high-exchange SBUF (H-SBUF) provides a greater anti-inflammatory effect than low-exchange SBUF (L-SBUF).
- To evaluate the clinical impact of H-SBUF on postoperative outcomes in pediatric cardiac surgery patients.
- To compare the efficacy of different SBUF exchange rates in mitigating CPB-associated inflammation.
Main Methods:
- A randomized, double-blind, parallel-group trial (ULTRA trial) involving 96 pediatric patients (<15 kg) undergoing cardiac surgery with CPB.
- Patients were randomized 1:1 to receive either H-SBUF or L-SBUF during CPB, stratified by STAT score.
- Primary outcome: peak postoperative vasoactive-ventilation-renal score. Secondary outcomes: organ dysfunction markers, biomarker concentrations (cytokines, chemokines, complement).
Main Results:
- The study is ongoing; primary and secondary outcome data are being collected.
- Biomarker data on cytokine, chemokine, and complement factor concentrations will be analyzed.
- Clinical outcomes including acute kidney injury, ventilation duration, and low cardiac output syndrome are being assessed.
Conclusions:
- The ULTRA trial aims to determine the clinical effectiveness of H-SBUF in reducing inflammation and improving outcomes after pediatric cardiac surgery.
- Findings will inform the use of SBUF in managing CPB-induced inflammatory responses.
- This research may lead to optimized strategies for pediatric cardiac surgery recovery.
Introduction:
Surgical repair is the standard of care for most infants and children with congenital heart disease. Cardiopulmonary bypass (CPB) is required to facilitate these operations but elicits a systemic inflammatory response, leading to postoperative organ dysfunction, morbidity and prolonged recovery after the surgery. Subzero-balance ultrafiltration (SBUF) has been shown to extract proinflammatory cytokines continuously throughout the CPB exposure. We hypothesize that a high-exchange SBUF (H-SBUF) will have a clinically relevant anti-inflammatory effect compared with a low-exchange SBUF (L-SBUF).
Methods And Analysis:
The ULTrafiltration to enhance Recovery After paediatric cardiac surgery (ULTRA) trial is a randomised, double-blind, parallel-group randomised trial conducted in a single paediatric cardiac surgery centre. Ninety-six patients less than 15 kg undergoing cardiac surgery with CPB will be randomly assigned to H-SBUF during CPB or L-SBUF during CPB in a 1:1 ratio with stratification by The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score 1 and STAT score 2-5. The primary outcome is peak postoperative vasoactive-ventilation-renal score. Time series and peak values of vasoactive-ventilation renal score, vasoactive-inotrope score, ventilation index and oxygenation index will be collected. Secondary clinical outcomes include acute kidney injury, ventilator-free days, inotrope-free days, low cardiac output syndrome, mechanical circulatory support, intensive care unit length of stay and operative mortality. Secondary biomarker data include cytokine, chemokine and complement factor concentrations at baseline before CPB, at the end of CPB exposure and 24 hours following CPB. Analyses will be conducted on an intention-to-treat principle.
Ethics And Dissemination:
The study has ethics approval (#1024932 dated August 31, 2021) and enrolment commenced in September 2021. The primary manuscript and any subsequent analyses will be submitted for peer-reviewed publication.
Trial Registration Number:
NCT04920643.
