An observational study in Congenital Heart Disease, sponsored by Claudia Herbst. Completed at 1 site in Austria. Open to participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by Claudia Herbst · Observational
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.
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.
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.
Exclusion Criteria:
Change of Copeptin concentrations
Change of Copeptin concentrations between the baseline and first postoperative measurement
Time frame: baseline and up to one day
Intubation
Duration of intubation time
Time frame: up to one day
Cardiopulmonary bypass
Total time of cardiopulmonary bypass and aortic cross clamp time.
Time frame: up to one day
ICU stay
Length of ICU stay
Time frame: 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
Time frame: up to one day
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