Clinical trial NCT05154864: Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study
Official title: The Optimal Ultrafiltration Protocol in Pediatric Cardiac Surgery: An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Inflammation
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 40
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Inflammatory Mediator Analysis
timeFrame: Plasma and ultrafiltrate effluent at pre-specified time points: Pre-Sternotomy (20min), Post-Sternotomy (30 min), every 30 minutes during cardiopulmonary bypass, 0 hours post-ultrafiltration, 12 hours post-ultrafiltration, 24 hours post-ultrafiltration
Secondary outcomes:
measure: Vasoactive-Ventilation-Renal (VVR) Score
timeFrame: Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.
measure: Vasoactive-Inotrope Score (VIS)
timeFrame: Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.
measure: Ventilation Index (VI)
timeFrame: Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.
measure: Oxygenation Index (OI)
timeFrame: Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.
measure: Ventilation Time
timeFrame: Through study completion, an average of 1 week.
measure: Intensive Care Unit Length of Stay
timeFrame: Through study completion, an average of 1 week.
measure: Acute Kidney Injury
timeFrame: Through study completion, an average of 1 week.
Other outcomes:
measure: Arterial Blood Gas
timeFrame: Pre-specified time points: Pre-Sternotomy (20min), Post-Sternotomy (30 min), every 30 minutes during cardiopulmonary bypass, 0,12,24,48,72,96,120 hours post-ultrafiltration.
measure: Red Blood Cell Transfusion
timeFrame: Measured through 24-hours post-operative
measure: Plasma Transfusion
timeFrame: Measured through 24-hours post-operative
measure: Platelet Transfusion
timeFrame: Measured through 24-hours post-operative
measure: Complete Blood Counts
timeFrame: Pre-specified time points: baseline, ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.
measure: Total Chest Tube Output
timeFrame: Through study completion, an average of 1 week.
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
References:
citation: 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.
citation: 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.