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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Cardiac Failure Acute
• Intervention / Treatment: Diagnostic test: dobutamine; Diagnostic test: norepinephrine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Jette, Vlaams Brabant, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: dobutamine; Cardiac failure	Diagnostic test: dobutamine; evaluation of effects of dobutamine on dynamic arterial elastance in cardiac failure
Other: norepinephrine; Sepsis	Diagnostic test: norepinephrine; evaluation of effects of norepinephrine on dynamic arterial elastance in sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eadyn estimation on haemodynamic monitor	display on the hemodynamic monitor	from 30 to 90 minutes after increase with 20% of vasoactive medication

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: jan Poelaert, PhD, MD, Universitair Ziekenhuis Brussel; Study Chair: Michel Vervoort, IR, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2019
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: dynamic arterial elastance; vasoactive medication
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Vasoconstrictor Agents; Norepinephrine; Dobutamine
• Other Study ID Numbers: Eadyn project 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No