Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery

NCT03316508 | Completed

• 1 other identifier: CHS1706001
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

copeptin; pediatric cardiac surgery; heart lung machine

Outcome Measures

Primary Outcomes (1)

• Change of Copeptin concentrations

  Change of Copeptin concentrations between the baseline and first postoperative measurement

  baseline and up to one day

Secondary Outcomes (4)

• Intubation

  up to one day

• Cardiopulmonary bypass

  up to one day

• ICU stay

  up to one day

• Complexity of procedures

  up to one day

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• ≤6 years of age
• CHD
• need of HLM for surgery
• Informed consent of parents
• not participating in other studies

You may not qualify if:

• Preoperative ventilatory support
• Preoperative circulatory support (ECMO, VAD)
• Diabetes insipidus
• Preoperative CPR
• Preoperative shock
• Preoperative sepsis
• Preoperative vasopressin application

Sponsors & Collaborators

• Claudia Herbst: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA blood samples

MeSH Terms

Conditions

Heart Defects, Congenital; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Claudia R Herbst, MD

  Medical University Vienna Department for Cardiac Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. univ.

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 20, 2017
• Study Start: June 14, 2017
• Primary Completion: October 1, 2018
• Study Completion: August 10, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

AU (1)