Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05154864
• Other study ID #: 1024869
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2021
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Inflammation

Intervention

Procedure:
• SBUF-SMUF
Intra-operative continuous ultrafiltration

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Bierer J, Henderson M, Stanzel R, Sett S, Horne D. Subzero balance - simple modified ultrafiltration (SBUF-SMUF) technique for pediatric cardiopulmonary bypass. Perfusion. 2021 Jun 18:2676591211027788. doi: 10.1177/02676591211027788. [Epub ahead of print] — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Arterial Blood Gas		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.
Other	Red Blood Cell Transfusion	volume in ml/kg	Measured through 24-hours post-operative
Other	Plasma Transfusion	volume in ml/kg	Measured through 24-hours post-operative
Other	Platelet Transfusion	volume in ml/kg	Measured through 24-hours post-operative
Other	Complete Blood Counts		Pre-specified time points: baseline, ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.
Other	Total Chest Tube Output	volume in ml/kg	Through study completion, an average of 1 week.
Primary	Inflammatory Mediator Analysis	Change in Concentrations of C1q, C2, C3, C3b, C4, C4b, C5, complement factor B, complement factor H, complement factor IC5a, CCL2 ,CCL3, CCL4, CCL5 (RANTES), CXCL1, CXCL2, CXCL10, GM-CSF, IL-1a, IL-1ß, IL-1Ra, IL-2, IL-6, CXCL8 (IL-8), IL-10, IL-12 (p70), IL-17/IL-17A, IL-33, TNF (TNF-a), TRAIL, IFN-?, E-Selectin, L-Selectin, P-Selectin, ICAM-1, VCAM-1, ET1.	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	Vasoactive-Ventilation-Renal (VVR) Score	Scale 0-60	Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.
Secondary	Vasoactive-Inotrope Score (VIS)	Scale 0-40	Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.
Secondary	Ventilation Index (VI)	Scale 0-40	Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.
Secondary	Oxygenation Index (OI)	Scale 0-20	Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.
Secondary	Ventilation Time		Through study completion, an average of 1 week.
Secondary	Intensive Care Unit Length of Stay	Standardized Discharge Criteria	Through study completion, an average of 1 week.
Secondary	Acute Kidney Injury	Kidney Disease Improving Global Outcomes criteria with Stages 1-3	Through study completion, an average of 1 week.