Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease

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 Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

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

Collaborators and Investigators

• Sponsor: Claudia Herbst
• Investigators: Principal Investigator: Claudia R Herbst, MD, Medical University Vienna Department for Cardiac Surgery

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): August 10, 2019

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: copeptin; pediatric cardiac surgery; heart lung machine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Pituitary Diseases; Heart Diseases; Heart Defects, Congenital; Diabetes Insipidus
• Other Study ID Numbers: CHS1706001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No