Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT03316508
• Lead Sponsor: Claudia Herbst

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.

Study Timeline

• Study Start: 2017-06-14
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Primary Completion: 2018-10-01
• Study Completion: 2019-08-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Copeptin concentrations	baseline and up to one day	Change of Copeptin concentrations between the baseline and first postoperative measurement

Secondary Outcome Measures

Name	Time	Method
Intubation	up to one day	Duration of intubation time
Cardiopulmonary bypass	up to one day	Total time of cardiopulmonary bypass and aortic cross clamp time.
Complexity of procedures	up to one day	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
ICU stay	up to one day	Length of ICU stay

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria