Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Congenital Heart Disease Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

SBUF-SMUF

Intervention Type PROCEDURE

Intra-operative continuous ultrafiltration

Interventions

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SBUF-SMUF

Intra-operative continuous ultrafiltration

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No