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Completed

NCT Number: NCT05154864

Ultrafiltration 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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SBUF-SMUF

Procedure

Intra-operative continuous ultrafiltration

Primary outcomes

  1. Inflammatory Mediator C3a

    Time frame: Sampled at the end of CPB

    C3a

  2. Inflammatory Mediator C5a

    Time frame: Measured at the end of CPB

  3. Inflammatory Mediator IL-6

    Time frame: Measured at the end of CPB

  4. Inflammatory Mediator IL-8

    Time frame: Measured at the end of CPB

Secondary outcomes

  1. Vasoactive-Ventilation-Renal Score

    Time frame: Upon ICU Admission

    Scale 0-60. Higher value resembles medical instability and a worse prognosis.

  2. Vasoactive-Inotrope Score

    Time frame: Upon ICU admission

    Scale 0-40. Higher value resembles medical instability and a worse prognosis.

  3. Ventilation Index

    Time frame: Upon ICU Admission

    Scale 0-40. Higher value resembles medical instability and a worse prognosis.

  4. Oxygenation Index

    Time frame: Upon ICU admission

    Scale 0-20. Higher value resembles medical instability and a worse prognosis.

  5. Ventilation Time

    Time frame: Upon ICU Admission

    Time on mechanical ventillator.

  6. Intensive Care Unit Length of Stay

    Time frame: Through study completion, an average of 1 week.

    Standardized Discharge Criteria

  7. Acute Kidney Injury

    Time frame: Through study completion, an average of 1 week.

    Kidney Disease Improving Global Outcomes criteria with Stages 1-3

Other outcomes

  1. Red Blood Cell Transfusion

    Time frame: Measured through 24-hours post-operative

    Number

  2. Plasma Transfusion

    Time frame: Measured through 24-hours post-operative

    number

  3. Platelet Transfusion

    Time frame: Measured through 24-hours post-operative

    volume in ml/kg

  4. Total Chest Tube Output

    Time frame: Through study completion, an average of 1 week.

    Volume in ml/kg

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 13, 2021
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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