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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBUF-SMUF | Procedure | Intra-operative continuous ultrafiltration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Mediator C3a | C3a | Sampled at the end of CPB |
| Inflammatory Mediator C5a | Measured at the end of CPB | |
| Inflammatory Mediator IL-6 | Measured at the end of CPB | |
| Inflammatory Mediator IL-8 | Measured at the end of CPB |
| Measure | Description | Time Frame |
|---|---|---|
| Vasoactive-Ventilation-Renal Score | Scale 0-60. Higher value resembles medical instability and a worse prognosis. | Upon ICU Admission |
| Vasoactive-Inotrope Score | Scale 0-40. Higher value resembles medical instability and a worse prognosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Red Blood Cell Transfusion | Number | Measured through 24-hours post-operative |
| Plasma Transfusion | number | Measured through 24-hours post-operative |
Inclusion Criteria:
Exclusion Criteria:
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Infants and children less than 30kg undergoing cardiac surgery with cardiopulmonary bypass and subzero-balance simple modified ultrafiltration (SBUF-SMUF).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34142611 | Background | 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. | |
| 31701831 | Background | Bierer 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. |
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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.
Recruitment occurred at the IWK Health Center in Halifax, Nova Scotia, between August 2020 and June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inflammatory Mediator C3a | C3a | Posted | Median | Inter-Quartile Range | pg/ml | Sampled at the end of CPB |
|
|
Until study completion, an average of 1 week.
No adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This is a single arm study on SBUF-SMUF with no comparator, it is for exploratory analysis only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Horne | Dalhousie University | Private | David.Horne@iwk.nshealth.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2020 | May 1, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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Patient plasma samples and ultrafiltrate effluent samples.
| Upon ICU admission |
| Ventilation Index | Scale 0-40. Higher value resembles medical instability and a worse prognosis. | Upon ICU Admission |
| Oxygenation Index | Scale 0-20. Higher value resembles medical instability and a worse prognosis. | Upon ICU admission |
| Ventilation Time | Time on mechanical ventillator. | Upon ICU Admission |
| Intensive Care Unit Length of Stay | Standardized Discharge Criteria | Through study completion, an average of 1 week. |
| Acute Kidney Injury | Kidney Disease Improving Global Outcomes criteria with Stages 1-3 | Through study completion, an average of 1 week. |
| Platelet Transfusion | volume in ml/kg | Measured through 24-hours post-operative |
| Total Chest Tube Output | Volume in ml/kg | Through study completion, an average of 1 week. |
| 39696469 | Derived | Bierer 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. |
| 37408044 | Derived | Bierer 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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| Secondary | Vasoactive-Ventilation-Renal Score | Scale 0-60. Higher value resembles medical instability and a worse prognosis. | Posted | Median | Inter-Quartile Range | Units on a scale. | Upon ICU Admission |
|
|
|
| Secondary | Vasoactive-Inotrope Score | Scale 0-40. Higher value resembles medical instability and a worse prognosis. | Posted | Median | Inter-Quartile Range | Units on a scale. | Upon ICU admission |
|
|
|
| Secondary | Ventilation Index | Scale 0-40. Higher value resembles medical instability and a worse prognosis. | Posted | Median | Inter-Quartile Range | Units on a scale. | Upon ICU Admission |
|
|
|
| Secondary | Oxygenation Index | Scale 0-20. Higher value resembles medical instability and a worse prognosis. | Posted | Median | Inter-Quartile Range | Units on a scale. | Upon ICU admission |
|
|
|
| Secondary | Ventilation Time | Time on mechanical ventillator. | Posted | Median | Inter-Quartile Range | hours | Upon ICU Admission |
|
|
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| Secondary | Intensive Care Unit Length of Stay | Standardized Discharge Criteria | Posted | Median | Inter-Quartile Range | hours | Through study completion, an average of 1 week. |
|
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| Secondary | Acute Kidney Injury | Kidney Disease Improving Global Outcomes criteria with Stages 1-3 | Posted | Number | Participants with AKI. | Through study completion, an average of 1 week. |
|
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| Other Pre-specified | Red Blood Cell Transfusion | Number | Posted | Median | Inter-Quartile Range | ml/kg | Measured through 24-hours post-operative |
|
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| Other Pre-specified | Plasma Transfusion | number | Posted | Median | Inter-Quartile Range | ml/kg | Measured through 24-hours post-operative |
|
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| Other Pre-specified | Platelet Transfusion | volume in ml/kg | Posted | Median | Inter-Quartile Range | ml/kg | Measured through 24-hours post-operative |
|
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| Other Pre-specified | Total Chest Tube Output | Volume in ml/kg | Posted | Median | Inter-Quartile Range | ml/kg | Through study completion, an average of 1 week. |
|
|
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| Primary | Inflammatory Mediator C5a | Posted | Median | Inter-Quartile Range | pg/ml | Measured at the end of CPB |
|
|
|
| Primary | Inflammatory Mediator IL-6 | Posted | Median | Inter-Quartile Range | pg/ml | Measured at the end of CPB |
|
|
|
| Primary | Inflammatory Mediator IL-8 | Posted | Median | Inter-Quartile Range | pg/ml | Measured at the end of CPB |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |