Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Congenital Heart Disease
• Intervention / Treatment: Procedure: SBUF-SMUF

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • IWK Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants and children less than 30kg undergoing cardiac surgery with cardiopulmonary bypass and subzero-balance simple modified ultrafiltration (SBUF-SMUF).

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: SBUF-SMUF; Intra-operative continuous ultrafiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet Transfusion	volume in ml/kg	Measured through 24-hours post-operative
Red Blood Cell Transfusion	Number	Measured through 24-hours post-operative
Plasma Transfusion	number	Measured through 24-hours post-operative
Total Chest Tube Output	Volume in ml/kg	Through study completion, an average of 1 week.

Collaborators and Investigators

• Sponsor: IWK Health Centre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Inflammation; Heart Defects, Congenital
• Other Study ID Numbers: 1024869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No