Congenital Heart Disease in Children, Congenital Heart Surgery, Fontan Physiology
Conditions
Keywords
biomarker, sst2, congenital heart surgery
Brief summary
Patients younger than 18 scheduled for congenital heart surgery will be assessed during and post-operatively as well as at the first follow-up after 9-12 month for the novel biomarker sST2. We will assess the marker independently and in evaluation with other blood biomarkers to evaluate sings of heart failure. Compared to established biomarkers, sST2 promises thereby to be less variable to factors like age or acute kidney injury, rendering it potentially more reliable in the field of congenital cardiac surgery.
Detailed description
Single-center prospective biomarker validation study for Soluble suppression of tumorigenicity 2 (sST2). All data will be collected upfront to ensure accuracy. The study's findings aim to improve risk stratification and guide better management for pediatric cardiac surgery patients. Congenital Heart Disease (CHD) is the most common congenital abnormality, affecting about 1 in 100 live births. While surgical interventions have significantly improved survival rates, a considerable number of patients experience long-term complications like ventricular dysfunction and heart failure, which are major causes of death. Biomarkers are crucial tools that can aid clinicians in risk stratification, treatment guidance, and predicting outcomes. sST2 has shown utility in adult heart surgery cases and is included in the guidelines of the American Heart Association (AHA), while it's use in pediatric cases is largely unexplored. This study tests if sST2 as biomarker can be a useful prognostic tool for children with CHD undergoing cardiac surgery. The primary objective is to assess if a specific cut-off level of post-surgery sST2 can predict future heart failure. Secondary objectives include comparing sST2 to other established biomarkers.
Interventions
None listed
Sponsors
University Children's Hospital, Zurich
Martin Schweiger
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Consented for cardiopulmonary bypass surgery for cardiac reason * Conversational skills in German (by child and/or representative) to be able to fully understand and sign a written consent in German language
Exclusion criteria
* Know genetic life limiting conditions * Syndrome patients who are scheduled or highly likely to be operated on more than one organ * Body weight at time of surgery less than 2.5 kg * Being recruited and enrolled for an interventional study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surrogates of Heart Failure | 1 year post surgery | Correlation of sST2 Levels with compound outcome of number of events of combined events of Death, need for MCS (Mechanical Circulatory Support) or Heart Transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Length of Stay | 30 days after index operation | Time between operation and discharge from hospital |
| Length of intubation | 30 days after index operation | Days necessary to wean patient from mechanical ventilatory support post surgery. |
| 30 day Mortality | 30 days after index operation | Number of early deaths (30 days post surgery) |
| Unplanned hospital re-admission | 30 days after index operation | Binary outcome, if patients is re-admitted for a reason related to his surgical intervention to hospital after being discharged. |
| Signs of upcoming heart failure, determined by cardiac echo | 30 days after index operation | Echocardiographic signs of imminent heart failure |
| Length of Stay on ICU | 30 days after index operation | Time between operation and discharge from the intensive care unit (ICU) |
Countries
Switzerland
Contacts
Primary ContactMartin Schweiger, Prof, MD, MBA
Backup ContactClemens Haselmann, MD
Outcome results
None listed