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Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery

C

Claudia Herbst

Status

Completed

Conditions

Congenital Heart Disease

Study type

Observational

Funder types

Other

Identifiers

NCT03316508
CHS1706001

Details and patient eligibility

About

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.

Full 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.

Enrollment

81 patients

Sex

All

Ages

Under 6 years old

Volunteers

No Healthy Volunteers

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

Trial design

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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