Congenital Heart Disease, Inflammation
Conditions
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.
Interventions
PROCEDURESBUF-SMUF
Intra-operative continuous ultrafiltration
Sponsors
IWK Health Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Mediator C3a | Sampled at the end of CPB | C3a |
| Inflammatory Mediator C5a | Measured at the end of CPB | — |
| Inflammatory Mediator IL-6 | Measured at the end of CPB | — |
| Inflammatory Mediator IL-8 | Measured at the end of CPB | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vasoactive-Ventilation-Renal Score | Upon ICU Admission | Scale 0-60. Higher value resembles medical instability and a worse prognosis. |
| Vasoactive-Inotrope Score | Upon ICU admission | Scale 0-40. Higher value resembles medical instability and a worse prognosis. |
| Ventilation Index | Upon ICU Admission | Scale 0-40. Higher value resembles medical instability and a worse prognosis. |
| Oxygenation Index | Upon ICU admission | Scale 0-20. Higher value resembles medical instability and a worse prognosis. |
| Ventilation Time | Upon ICU Admission | Time on mechanical ventillator. |
| Intensive Care Unit Length of Stay | Through study completion, an average of 1 week. | Standardized Discharge Criteria |
| Acute Kidney Injury | Through study completion, an average of 1 week. | Kidney Disease Improving Global Outcomes criteria with Stages 1-3 |
Countries
Canada
Participant flow
Recruitment details
Recruitment occurred at the IWK Health Center in Halifax, Nova Scotia, between August 2020 and June 2021.
Pre-assignment details
48 patients were screened, and 40 were eligible and consented to proceed with the study protocol. All 40 patients received the study treatment as specified.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 40 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 40 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
None listed