CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled / 40 target
Drug / intervention
SBUF-SMUFprocedure
Likely dose
30 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05154864
NCT05154864N/ACompletedOn Track (0.6/mo)Completion was 60mo ago

The Optimal Ultrafiltration Protocol in Pediatric Cardiac Surgery: An Observational Cohort Study

IWK Health Centre·observational·Posted Dec 13, 2021·Updated Jun 2, 2026

In Brief

An observational study evaluating SBUF-SMUF for Congenital Heart Disease and Inflammation. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Infants and children undergoing cardiac surgery with cardiopulmonary bypass (CPB) can experience systemic inflammation that prolongs post-operative recovery. Ultrafiltration is an intra-opreative technique that is hypothesized to extract circulating inflammatory mediators during the CPB time. There have been only a few small studies looking at a limited number of inflammatory marker profiles in this context. Our institution uses an innovative form of ultrafiltration "subzero-balance simple-modified ultrafiltration" (SBUF-SMUF) throughout the entire CPB time. SBUF-SMUF has been our standard of care for the last 5 years. This observational seeks to describe the clinical and immunologic outcomes of infants and children undergoing cardiac surgery with CBP and SBUF-SMUF.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 13, 2021
Enrollment StartAug 1, 2020
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.6 years ago

Arms & Interventions

SBUF-SMUFother

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.

Procedure: SBUF-SMUF

Interventions

SBUF-SMUFprocedure

Intra-operative continuous ultrafiltration