Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Heart Failure.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorMartin Schweiger

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

All patients in defined age scheduled for congenital cardiac surgery

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

225 Participants
are grouped into 1 trial group
Group A: Patients planned for congenital cardiac surgery

Trial outcomes

Primary outcomes

1

Surrogates of Heart Failure

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

Time frame
1 year post surgery

Secondary outcomes

1

30 day Mortality

Number of early deaths (30 days post surgery)

Time frame
30 days after index operation
2

Overall Length of Stay

Time between operation and discharge from hospital

Time frame
30 days after index operation
3

Length of intubation

Days necessary to wean patient from mechanical ventilatory support post surgery.

Time frame
30 days after index operation
4

Length of Stay on ICU

Time between operation and discharge from the intensive care unit (ICU)

Time frame
30 days after index operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Martin Schweiger

Lead sponsor

University Children's Hospital, Zurich

Sponsor institution

University Children's Hospital, Zurich

Collaborator