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NCT Number: NCT03316508

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change of Copeptin concentrations

    Time frame: baseline and up to one day

    Change of Copeptin concentrations between the baseline and first postoperative measurement

Secondary outcomes

  1. Intubation

    Time frame: up to one day

    Duration of intubation time

  2. Cardiopulmonary bypass

    Time frame: up to one day

    Total time of cardiopulmonary bypass and aortic cross clamp time.

  3. ICU stay

    Time frame: up to one day

    Length of ICU stay

  4. Complexity of procedures

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Claudia Herbst

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 20, 2017
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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