Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery

Study Overview
=================
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.

Official Title
-----------------
Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Copeptin concentrations | Change of Copeptin concentrations between the baseline and first postoperative measurement | baseline and up to one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation | Duration of intubation time | up to one day | 
| Cardiopulmonary bypass | Total time of cardiopulmonary bypass and aortic cross clamp time. | up to one day | 
| ICU stay | Length of ICU stay | up to one day | 
| Complexity of procedures | The surgical complexity of the procedures undergone by the patients will be shown by using a scoring system developed for this purpose named Aristotle Score | up to one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
copeptin, pediatric cardiac surgery, heart lung machine