Copeptin- Relevance as a Perioperative Marker in Pediatri... | NCT03316508

Studies
Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery

NCT03316508

Sponsor

Claudia Herbst

Status

Completed

Last Update Posted

Sep 11, 2019Actual

Enrollment

81Actual

Phase

Not provided

Conditions

Congenital Heart Disease

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 14, 2017Actual

Primary Completion Date

Oct 1, 2018Actual

Completion Date

Aug 10, 2019Actual

First Submitted Date

Oct 2, 2017

First Submission Date that Met QC Criteria

Oct 17, 2017

First Posted Date

Oct 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2019

Last Update Posted Date

Sep 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

81Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Years

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia R Herbst, MD	Medical University Vienna Department for Cardiac Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		1090	Austria

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 17, 2017	Oct 2, 2017	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Apr 27, 2017	Oct 2, 2017	ICF_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital
D003919	Diabetes Insipidus

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

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