Related Experiment Video
Updated: Jan 31, 2026

Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
High-Exchange Ultrafiltration to Enhance Recovery After Pediatric Cardiac Surgery: The ULTRA Randomized Controlled
Joel David Bierer1, Roger Stanzel2, Mark Henderson2
1Division of Cardiac Surgery, Dalhousie University, Halifax, Nova Scotia, Canada.
Insights
High-exchange ultrafiltration during pediatric cardiac surgery did not improve clinical outcomes or reduce inflammation compared to low-exchange methods. This study found no significant differences in key patient recovery markers between the two ultrafiltration strategies.
Area of Science:
- Cardiovascular Surgery
- Pediatric Critical Care
- Inflammation Research
Background:
- Pediatric cardiac surgery utilizing cardiopulmonary bypass (CPB) is frequently linked to systemic inflammation.
- Investigating novel strategies to mitigate this inflammatory response is crucial for improving patient outcomes.
Purpose of the Study:
- To evaluate the clinical immunomodulatory effect of continuous high-exchange ultrafiltration during CPB in pediatric patients.
- To determine if high-exchange ultrafiltration impacts post-operative recovery and inflammatory markers.
Main Methods:
- A single-center, double-blinded trial randomized pediatric patients (<15 kg) undergoing cardiac surgery to either high-exchange (H-SBUF, 60 ml/kg/hr) or low-exchange (L-SBUF, 6 ml/kg/hr) subzero-balance ultrafiltration during CPB.
- The primary outcome was the peak post-operative vasoactive-ventilation-renal (VVR) score, with secondary outcomes including acute kidney injury, low cardiac output syndrome, and inflammatory mediator levels.
Main Results:
- No significant difference was observed in the primary outcome (peak VVR score) between the H-SBUF and L-SBUF groups (p = 0.67).
- Secondary clinical outcomes such as acute kidney injury, low cardiac output syndrome, ventilation time, inotrope use, and length of stay were similar between groups.
- The H-SBUF group showed a higher fold change for IL-1α, P-selectin, and VCAM-1, but thirty-six other inflammatory mediators did not differ significantly.
Conclusions:
- Continuous high-exchange subzero-balance ultrafiltration during CPB did not reduce peak VVR scores in pediatric cardiac surgery patients compared to low-exchange ultrafiltration.
- No significant differences in secondary clinical outcomes or the overall immunologic profile were found between the high- and low-exchange ultrafiltration groups.
Background:
Pediatric cardiac surgery with cardiopulmonary bypass (CPB) is associated with systemic inflammation. This trial aimed to determine whether continuous high-exchange ultrafiltration during CPB has a clinical immunomodulatory effect.
Methods:
This single-center, double-blind trial enrolled pediatric patients weighing <15 kg undergoing cardiac surgery who were randomly allocated to continuous high-exchange subzero-balance ultrafiltration (H-SBUF; 60 mL/kg per hour effluent extraction) or continuous low-exchange subzero-balance ultrafiltration (L-SBUF; 6 mL/kg per hour effluent extraction) administered during CPB. The primary outcome was peak postoperative vasoactive-ventilation-renal (VVR) score. Secondary outcomes included acute kidney injury, low cardiac output syndrome, health care utilization, and inflammatory mediator fold change throughout CPB (NCT04920643).
Results:
A total of 104 patients were randomly allocated to H-SBUF (n = 52) or L-SBUF (n = 52). The primary outcome was similar between groups as the peak VVR score was 26.9 (2.1-77.9) in the H-SBUF group and 27.8 (0.8-76.7) in the L-SBUF group (P = .67). There were no operative deaths and no significant differences in acute kidney injury, low cardiac output syndrome, ventilation time, inotropic agent use time, intensive care unit stay, or hospital length of stay (P > .05). The H-SBUF group had a higher fold change for interleukin-1α, P-selectin, and vascular cell adhesion molecule 1 (P < .05), whereas 36 other mediators were not significantly different between groups (P > .05).
Conclusions:
In pediatric patients undergoing cardiac surgery with CPB, continuous high-exchange SBUF did not reduce peak VVR score compared with low-exchange SBUF. Furthermore, there were no differences in secondary clinical outcomes, and the immunologic profile was largely similar between groups.
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Statistical Software for Data Analysis and Clinical Trials
Social Exchange Theory
Gas Exchange and Transport
Trial and Error and Algorithm

