Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study

NCT05154864 | Completed Results

• 1 other identifier: 1024869
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease; Inflammation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Vasoactive-Ventilation-Renal Score

  Upon ICU Admission

• Vasoactive-Inotrope Score

  Upon ICU admission

• Ventilation Index

  Upon ICU Admission

• Oxygenation Index

  Upon ICU admission

• Ventilation Time

  Upon ICU Admission

Other Outcomes (4)

• Red Blood Cell Transfusion

  Measured through 24-hours post-operative

• Plasma Transfusion

  Measured through 24-hours post-operative

• Platelet Transfusion

  Measured through 24-hours post-operative

Study Arms (1)

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

Interventions

SBUF-SMUF PROCEDURE

Intra-operative continuous ultrafiltration

SBUF-SMUF

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (4)

• 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.

  PMID: 34142611 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.

  PMID: 31701831 BACKGROUND

• 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.

  PMID: 39696469 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.

  PMID: 37408044 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patient plasma samples and ultrafiltrate effluent samples.

MeSH Terms

Conditions

Heart Defects, Congenital; Inflammation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This is a single arm study on SBUF-SMUF with no comparator, it is for exploratory analysis only.

Results Point of Contact

• Title: David Horne
• Organization: Dalhousie University

David.Horne@iwk.nshealth.ca

Private

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Congenital Cardiac Surgeon

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 13, 2021
• Study Start: August 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 2, 2026
• Results First Posted: June 2, 2026

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)