Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery

NCT ID: NCT03316508

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2019-08-10

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.

Conditions

Congenital Heart Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Claudia Herbst

OTHER

Sponsor Role: lead

Responsible Party

Claudia Herbst

Dr. med. univ.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claudia R Herbst, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna Department for Cardiac Surgery

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CHS1706001

Identifier Type: -

Identifier Source: org_study_id