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Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study

I

IWK Health Centre

Status

Completed

Conditions

Inflammation
Congenital Heart Disease

Treatments

Procedure: SBUF-SMUF

Study type

Observational

Funder types

Other

Identifiers

NCT05154864
1024869

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

Under 15 years old

Volunteers

No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

SBUF-SMUF
Description:
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.
Treatment:
Procedure: SBUF-SMUF

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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