Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery

Congenital Heart Disease Clinical Trial

Official title:

Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316508
• Other study ID #: CHS1706001
• Status: Completed
• Start date: June 14, 2017
• Est. completion date: August 10, 2019

Study information

• Verified date: September 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 10, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Diabetes Insipidus
• Heart Diseases

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Claudia Herbst

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Copeptin concentrations	Change of Copeptin concentrations between the baseline and first postoperative measurement	baseline and up to one day
Secondary	Intubation	Duration of intubation time	up to one day
Secondary	Cardiopulmonary bypass	Total time of cardiopulmonary bypass and aortic cross clamp time.	up to one day
Secondary	ICU stay	Length of ICU stay	up to one day
Secondary	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