Trial Outcomes & Findings for Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study (NCT NCT05154864)

Results Overview

C3a

Recruitment status

COMPLETED

Target enrollment

40 participants

Primary outcome timeframe

Sampled at the end of CPB

Results posted on

2026-06-02

Participant Flow

Recruitment occurred at the IWK Health Center in Halifax, Nova Scotia, between August 2020 and June 2021.

48 patients were screened, and 40 were eligible and consented to proceed with the study protocol. All 40 patients received the study treatment as specified.

Participant milestones

Participant milestones
Measure	SBUF-SMUF All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Age, Categorical <=18 years	40 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants
Sex: Female, Male Female	17 Participants n=9 Participants
Sex: Female, Male Male	23 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants
Race (NIH/OMB) White	0 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	40 Participants n=9 Participants

PRIMARY outcome

Timeframe: Sampled at the end of CPB

C3a

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Inflammatory Mediator C3a	30 pg/ml Interval 24.1 to 36.5

PRIMARY outcome

Timeframe: Measured at the end of CPB

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Inflammatory Mediator C5a	106.4 pg/ml Interval 56.2 to 192.6

PRIMARY outcome

Timeframe: Measured at the end of CPB

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Inflammatory Mediator IL-6	375.1 pg/ml Interval 179.2 to 563.8

PRIMARY outcome

Timeframe: Measured at the end of CPB

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Inflammatory Mediator IL-8	63.7 pg/ml Interval 31.3 to 108.7

SECONDARY outcome

Timeframe: Upon ICU Admission

Scale 0-60. Higher value resembles medical instability and a worse prognosis.

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Vasoactive-Ventilation-Renal Score	19 Units on a scale. Interval 8.0 to 28.0

SECONDARY outcome

Timeframe: Upon ICU admission

Scale 0-40. Higher value resembles medical instability and a worse prognosis.

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Vasoactive-Inotrope Score	7 Units on a scale. Interval 2.0 to 10.0

SECONDARY outcome

Timeframe: Upon ICU Admission

Scale 0-40. Higher value resembles medical instability and a worse prognosis.

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Ventilation Index	11 Units on a scale. Interval 0.0 to 19.0

SECONDARY outcome

Timeframe: Upon ICU admission

Scale 0-20. Higher value resembles medical instability and a worse prognosis.

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Oxygenation Index	2 Units on a scale. Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Upon ICU Admission

Time on mechanical ventillator.

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Ventilation Time	19 hours Interval 0.0 to 70.0

SECONDARY outcome

Timeframe: Through study completion, an average of 1 week.

Standardized Discharge Criteria

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Intensive Care Unit Length of Stay	62 hours Interval 24.0 to 95.0

SECONDARY outcome

Timeframe: Through study completion, an average of 1 week.

Kidney Disease Improving Global Outcomes criteria with Stages 1-3

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Acute Kidney Injury	3 Participants with AKI.

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured through 24-hours post-operative

Number

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Red Blood Cell Transfusion	0 ml/kg Interval 0.0 to 13.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured through 24-hours post-operative

number

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Plasma Transfusion	0 ml/kg Interval 0.0 to 5.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured through 24-hours post-operative

volume in ml/kg

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Platelet Transfusion	0 ml/kg Interval 0.0 to 5.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 1 week.

Volume in ml/kg

Outcome measures

Outcome measures
Measure	SBUF-SMUF n=40 Participants All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr.
Total Chest Tube Output	9 ml/kg Interval 7.0 to 13.0

Adverse Events

SBUF-SMUF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Horne

Dalhousie University

Phone: Private

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place