Clinical trial NCT03316508: Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery
Official title: Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: copeptin
pediatric cardiac surgery
heart lung machine
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 81
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of 81 patients (neonates, infants, children) with congenital heart disease and the need of cardiac surgery with a heart-lung machine. Parental consent after pre-operative consultation and informing about the study is required.

Brief summary: This study evaluates the relevance of Copeptin in children with congenital heart disease undergoing cardiac surgery with the need of cardiopulmonary bypass. Three blood samples are taken of each patient. The first and second sample are collected in the operation room before and after the procedure and the third sample on the first postoperative day at the intensive care unit.

Detailed description: Objective:

Vasopressin is a hormone secreted by the posterior pituitary gland. Its main functions are constriction of blood vessels and reabsorption of water and thereby regulating water balance and hemodynamics of the body. Copeptin is a cleavage product in the synthesis of vasopressin and is released in equimolar amounts. Its stability makes it easier to determine the amount of vasopressin. It is known, that the use of a heart-lung machine in cardiac procedures has effects on the water balance of the body and may affect the vasopressin secretion.

The aim of this prospective clinical trial is, to figure out if copeptin would be suitable for perioperative risk evaluation in neonates and children with congenital heart disease after surgery with the use of a heart-lung machine.

Hypotheses:

The primary outcome endpoint of this study is the change in copeptin concentration perioperatively in patients with congenital heart disease, with the use of heart-lung machine.

Secondary outcome endpoints are correlations between copeptin concentration and complexity of the procedure (based on the aristotle basic score), clinical status and the perfusion times of the heart-lung machine.

Eligibility criteria: Inclusion Criteria:

* ≤6 years of age
* CHD
* need of HLM for surgery
* Informed consent of parents
* not participating in other studies

Exclusion Criteria:

* Preoperative ventilatory support
* Preoperative circulatory support (ECMO, VAD)
* Diabetes insipidus
* Preoperative CPR
* Preoperative shock
* Preoperative sepsis
* Preoperative vasopressin application

Primary outcomes:
measure: Change of Copeptin concentrations
timeFrame: baseline and up to one day
Secondary outcomes:
measure: Intubation
timeFrame: up to one day
measure: Cardiopulmonary bypass
timeFrame: up to one day
measure: ICU stay
timeFrame: up to one day
measure: Complexity of procedures
timeFrame: up to one day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University Vienna Department for Cardiac Surgery
name: Claudia R Herbst, MD
role: PRINCIPAL_INVESTIGATOR
References: