Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.

NCT03621618 | Withdrawn

• 1 other identifier: Eadyn project 2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the study is to determine Eadyn ( = PPV/SVV) as a functional measure of arterial load, in conjunction with other actual afterload indices, systemic vascular resistance and arterial elastance. A secondary aim is the assessment of the influences of vasopressors and inotropic drugs on Eadyn, as a parameter of ventriculo-arterial coupling.

Conditions

Sepsis; Cardiac Failure Acute

Keywords

vasoactive medication; dynamic arterial elastance

Outcome Measures

Primary Outcomes (1)

• Change of Dynamic Arterial Elastance (Eadyn)

  display on the hemodynamic monitor

  baseline and from 30-90 minutes after increase with 20% of vasoactive medication and haemodynamic stabilisation

Secondary Outcomes (1)

• Eadyn estimation on haemodynamic monitor

  from 30 to 90 minutes after increase with 20% of vasoactive medication

Study Arms (2)

dobutamine

OTHER

Cardiac failure

Diagnostic Test: dobutamine

norepinephrine

OTHER

Sepsis

Diagnostic Test: norepinephrine

Interventions

dobutamine DIAGNOSTIC_TEST

evaluation of effects of dobutamine on dynamic arterial elastance in cardiac failure

dobutamine

norepinephrine DIAGNOSTIC_TEST

evaluation of effects of norepinephrine on dynamic arterial elastance in sepsis

norepinephrine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- ICU patients, treated/supported with noradrenalin or dobutamine.

You may not qualify if:

• Septic shock
• Aortic valve regurgitation and defect of septum
• Severe aortic sclerosis, aortic prosthesis
• Severe hypertension (MAP \> 130 mmHg)
• Cardiac arrhythmia
• Tachycardia with a heart rate higher than 150 bpm
• Age below 18 or above 75 y
• Patient height below 120 cm (48") or above 230 cm (90")
• Patient weight less than 30 kg (67 lbs.) or greater than 155 kg (341 lbs.)
• Intra-aortic balloon pump

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, 1090, Belgium

Location

MeSH Terms

Conditions

Sepsis

Interventions

Echocardiography, Stress

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Jan Poelaert, PhD, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Michel Vervoort, IR

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: August 8, 2018
• Study Start: March 31, 2019
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: November 18, 2025

Record last verified: 2025-10

Locations

BE (1)