Congenital Heart DiseaseNCT05154864
Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study
An observational study of Congenital Heart Disease and Inflammation, run by IWK Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Congenital Heart Disease, Inflammation
- What is being tested?
- SBUF-SMUF
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Infants and children less than 30kg undergoing cardiac surgery with cardiopulmonary bypass and subzero-balance simple modified ultrafiltration (SBUF-SMUF).
Who may be able to join
- Congenital cardiac patients (< 30kg) that have been consented to a planned cardiac surgery procedure requiring cardiopulmonary bypass at the IWK Health Centre.
- Patient or family consent to participate in the study.
Who cannot join
- Patient or family refusal to participate.
- Known genetic syndrome with multi-organ abnormalities and immune dysfunction such as DiGeorge Syndrome, Trisomy 18 or 13, Noonan syndrome.
- Known immunodeficiency syndrome or bone marrow pathology.
- Severe liver disease with abnormal synthetic liver function tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Optimal Ultrafiltration Protocol in Pediatric Cardiac Surgery: An Observational Cohort Study
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.
- Conditions
- Congenital Heart Disease, Inflammation
- Being tested
- SBUF-SMUF
- Medical subject headings
- Heart Defects, Congenital, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBUF-SMUFProcedure or surgery
Intra-operative continuous ultrafiltration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: SBUF-SMUF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Mediator C3a
C3a
Measured: Sampled at the end of CPB
Inflammatory Mediator C5a
Measured: Measured at the end of CPB
Inflammatory Mediator IL-6
Measured: Measured at the end of CPB
Inflammatory Mediator IL-8
Measured: Measured at the end of CPB
Secondary outcomes (7)
Vasoactive-Ventilation-Renal Score
Scale 0-60. Higher value resembles medical instability and a worse prognosis.
Measured: Upon ICU Admission
Vasoactive-Inotrope Score
Scale 0-40. Higher value resembles medical instability and a worse prognosis.
Measured: Upon ICU admission
Ventilation Index
Scale 0-40. Higher value resembles medical instability and a worse prognosis.
Measured: Upon ICU Admission
Oxygenation Index
Scale 0-20. Higher value resembles medical instability and a worse prognosis.
Measured: Upon ICU admission
Ventilation Time
Time on mechanical ventillator.
Measured: Upon ICU Admission
Intensive Care Unit Length of Stay
Standardized Discharge Criteria
Measured: Through study completion, an average of 1 week.
Acute Kidney Injury
Kidney Disease Improving Global Outcomes criteria with Stages 1-3
Measured: Through study completion, an average of 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Aug 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. David Horne, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154864
- Sponsor's protocol ID
- 1024869
- Status last verified
- Dec 2021
- First submitted
- 8 Nov 2021
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bierer J, Henderson M, Stanzel R, Sett S, Horne D. Subzero balance - simple modified ultrafiltration (SBUF-SMUF) technique for pediatric cardiopulmonary bypass. Perfusion. 2022 Nov;37(8):785-788. doi: 10.1177/02676591211027788. Epub 2021 Jun 18.
PubMed 34142611Bierer J, Stanzel R, Henderson M, Sett S, Horne D. Ultrafiltration in Pediatric Cardiac Surgery Review. World J Pediatr Congenit Heart Surg. 2019 Nov;10(6):778-788. doi: 10.1177/2150135119870176.
PubMed 31701831Bierer J, Stanzel R, Henderson M, Sapp J, Andreou P, Marshall JS, Horne D. Unmasking culprits: novel analysis identifies complement factors as potential therapeutic targets to mitigate inflammation during children's heart surgery. Eur J Med Res. 2024 Dec 19;29(1):601. doi: 10.1186/s40001-024-02156-0.
PubMed 39696469Bierer J, Stanzel R, Henderson M, Sett S, Sapp J, Andreou P, Marshall JS, Horne D. Novel inflammatory mediator profile observed during pediatric heart surgery with cardiopulmonary bypass and continuous ultrafiltration. J Transl Med. 2023 Jul 5;21(1):439. doi: 10.1186/s12967-023-04255-8.
PubMed 37408044
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Ultrafiltration Protocol in Pediatric Cardiac Surgery: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05154864
- Acronym / sponsor ID
- 1024869
- Conditions
- Congenital Heart Disease, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Posted 2 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBUF-SMUF | – | Procedure: SBUF-SMUFAll 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. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants and children less than 30kg undergoing cardiac surgery with cardiopulmonary bypass and subzero-balance simple modified ultrafiltration (SBUF-SMUF).
Key inclusion criteria (2 listed)
- Congenital cardiac patients (< 30kg) that have been consented to a planned cardiac surgery procedure requiring cardiopulmonary bypass at the IWK Health Centre.
- Patient or family consent to participate in the study.
Key exclusion criteria (4 listed)
- Patient or family refusal to participate.
- Known genetic syndrome with multi-organ abnormalities and immune dysfunction such as DiGeorge Syndrome, Trisomy 18 or 13, Noonan syndrome.
- Known immunodeficiency syndrome or bone marrow pathology.
- Severe liver disease with abnormal synthetic liver function tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBUF-SMUFIntra-operative continuous ultrafiltration | Procedure or surgery | SBUF-SMUF |
Primary outcome
Inflammatory Mediator C3a
Time frame: Sampled at the end of CPB
C3a
Inflammatory Mediator C5a
Time frame: Measured at the end of CPB
Inflammatory Mediator IL-6
Time frame: Measured at the end of CPB
Inflammatory Mediator IL-8
Time frame: Measured at the end of CPB
7 secondary outcomes
Vasoactive-Ventilation-Renal Score
Time frame: Upon ICU Admission
Vasoactive-Inotrope Score
Time frame: Upon ICU admission
Ventilation Index
Time frame: Upon ICU Admission
Oxygenation Index
Time frame: Upon ICU admission
Ventilation Time
Time frame: Upon ICU Admission
Intensive Care Unit Length of Stay
Time frame: Through study completion, an average of 1 week.
Acute Kidney Injury
Time frame: Through study completion, an average of 1 week.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34142611Bierer J, Henderson M, Stanzel R, Sett S, Horne D. Subzero balance - simple modified ultrafiltration (SBUF-SMUF) technique for pediatric cardiopulmonary bypass. Perfusion. 2022 Nov;37(8):785-788. doi: 10.1177/02676591211027788. Epub 2021 Jun 18.
- Background: PubMed 31701831Bierer J, Stanzel R, Henderson M, Sett S, Horne D. Ultrafiltration in Pediatric Cardiac Surgery Review. World J Pediatr Congenit Heart Surg. 2019 Nov;10(6):778-788. doi: 10.1177/2150135119870176.
- Derived from this study: PubMed 39696469Bierer J, Stanzel R, Henderson M, Sapp J, Andreou P, Marshall JS, Horne D. Unmasking culprits: novel analysis identifies complement factors as potential therapeutic targets to mitigate inflammation during children's heart surgery. Eur J Med Res. 2024 Dec 19;29(1):601. doi: 10.1186/s40001-024-02156-0.
- Derived from this study: PubMed 37408044Bierer J, Stanzel R, Henderson M, Sett S, Sapp J, Andreou P, Marshall JS, Horne D. Novel inflammatory mediator profile observed during pediatric heart surgery with cardiopulmonary bypass and continuous ultrafiltration. J Transl Med. 2023 Jul 5;21(1):439. doi: 10.1186/s12967-023-04255-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Inflammation, run by IWK Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Mediator C3a (time frame: Sampled at the end of CPB). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05154864, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.