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

NCT ID: NCT03621618

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2023-06-02

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.

Detailed Description

Assessment of the cardiovascular status and haemodynamics comprise directly or indirectly cardiac output, which is determined by left ventricular preload, contractility, afterload and heart rate. Various haemodynamic monitors have been introduced in anaesthesia and ICU practice, providing cardiac output either non-invasively or invasively. The combined use of arterial pressure monitoring with these devices provides insight not only in cardiac output but offers bedside assessment of most determinants of cardiovascular function. Both pulse pressure variation (PPV) and stroke volume variation (SVV) have been described as dynamic descriptors of fluid responsiveness, a measure allowing optimization of preloading conditions if haemodynamics show signals of insufficient perfusion.

Arterial load can be assessed based on a two-element Windkessel model with a static and dynamic component. The static part consists of a resistive element (systemic vascular resistance: SVR = (MAP/C0)*80, with MAP, mean arterial pressure; CO, cardiac output) and a pulsatile component (net arterial compliance C = SV/arterial pulse pressure with SV, stroke volume). Arterial elastance is considered being an integrative variable, associating both steady elements and heart rate (Ea = .9*SAP/SV with EA, arterial elastance; SAP, systolic arterial pressure). The dynamic component Eadyn is the ratio of PPV and SVV during a mechanical ventilator cycle, providing a functional assessment of ventriculo-arterial coupling.

Combined use of arterial pressure tracing (or its non-invasive surrogate) and (non-) invasive stroke volume actually may provide an interesting framework for haemodynamic monitoring and subsequent optimization in many surgical, postoperative or ICU patients. This study aims to copy as good as possible the handling and the way of management as in a clinical setting.

Conditions

Sepsis; Cardiac Failure Acute

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

dobutamine

Cardiac failure

Group Type: OTHER

dobutamine

Intervention Type: DIAGNOSTIC_TEST

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

norepinephrine

Sepsis

Group Type: OTHER

norepinephrine

Intervention Type: DIAGNOSTIC_TEST

evaluation of effects of norepinephrine on dynamic arterial elastance in sepsis

Interventions

dobutamine

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

Intervention Type: DIAGNOSTIC_TEST

norepinephrine

evaluation of effects of norepinephrine on dynamic arterial elastance in sepsis

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Poelaert, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Michel Vervoort, IR

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Locations

universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, Belgium

Countries

Belgium

Other Identifiers

Eadyn project 2

Identifier Type: -

Identifier Source: org_study_id