NCT04745845

Brief Summary

The study aims to examine how noradrenaline in combination with venous return influences the energy transmission from heart to central circulation and arteries - also called arterio-ventricular coupling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

February 8, 2021

Last Update Submit

January 4, 2022

Conditions

Heart Diseases

Keywords

NoradrenalineHeart surgeryIntensive careCardiac physiology

Outcome Measures

Primary Outcomes (2)

  • Change in Cardiac Power

    Change in Cardiac Power in reaction to both different noradrenaline doses and states of fluid responsiveness. By logging invasive BP curve and tracing left ventricular outflow tract Velocity Time Integral (by echocardiography) simultaneously Total and Mean Cardiac Power (Watt) can be determined. Examining the response to different NA doses relative to fluid responsiveness the effect of NA on arterio-ventricular coupling can be examined.

    within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery

  • Change in Oscillatory Power Fraction

    Change in Oscillatory Power Fraction (OPF) in reaction to both different noradrenaline doses and states of fluid responsiveness. By logging invasive BP curve and tracing left ventricular outflow tract Velocity Time Integral (by echocardiography) simultaneously Total Cardiac Power (TCP, Watt) and Cardiac Power Output (CPO, Watt) can be determined. By subtracting CPO from TCP, OPF (in %) can be calculated. Examining the response to different NA doses relative to fluid responsiveness the effect of NA on arterio-ventricular coupling can be examined.

    within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery

Secondary Outcomes (2)

  • Change in single beat ventricular elastance

    within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery

  • Change in single beat arterial elastance

    within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery

Study Arms (1)

Noradrenalin

EXPERIMENTAL

treatment with 2 different NA concentrations in 2 different states of fluid responsiveness

Procedure: Noradrenalin

Interventions

NoradrenalinPROCEDURE

Norepinephrine challenge (concentration 'A' ) in fluid responsive position

Also known as: Anti-Trendelenburg position/Semiupright position (20degr)
Noradrenalin

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective coronary artery bypass graft surgery
  • requirement for Noradrenaline/Norepinephrine

You may not qualify if:

  • lack of informed consent
  • patient unsuitable for mean arterial pressure (MAP) elevation of 20mmHg
  • patient requiring different blood pressure range due to medical/surgical needs
  • poor image quality due to patient factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital, Dep. for Anesthesia & Intensive care. Section of cardiothoracic Anesthesia and -intensive Care.

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hilde Pleym (Head of Department), md, PhD

    St. Olavs Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 9, 2021

Study Start

March 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 5, 2022

Record last verified: 2022-01

Locations

NO(1)