Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.
Primary Purpose
Sepsis, Cardiac Failure Acute
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
dobutamine
norepinephrine
Sponsored by
About this trial
This is an interventional diagnostic trial for Sepsis focused on measuring vasoactive medication, dynamic arterial elastance
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
Sites / Locations
- universitair Ziekenhuis BrusselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
dobutamine
norepinephrine
Arm Description
Cardiac failure
Sepsis
Outcomes
Primary Outcome Measures
Change of Dynamic Arterial Elastance (Eadyn)
display on the hemodynamic monitor
Secondary Outcome Measures
Eadyn estimation on haemodynamic monitor
display on the hemodynamic monitor
Full Information
NCT ID
NCT03621618
First Posted
June 28, 2018
Last Updated
April 16, 2019
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT03621618
Brief Title
Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.
Official Title
Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 31, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Cardiac Failure Acute
Keywords
vasoactive medication, dynamic arterial elastance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dobutamine
Arm Type
Other
Arm Description
Cardiac failure
Arm Title
norepinephrine
Arm Type
Other
Arm Description
Sepsis
Intervention Type
Diagnostic Test
Intervention Name(s)
dobutamine
Intervention Description
evaluation of effects of dobutamine on dynamic arterial elastance in cardiac failure
Intervention Type
Diagnostic Test
Intervention Name(s)
norepinephrine
Intervention Description
evaluation of effects of norepinephrine on dynamic arterial elastance in sepsis
Primary Outcome Measure Information:
Title
Change of Dynamic Arterial Elastance (Eadyn)
Description
display on the hemodynamic monitor
Time Frame
baseline and from 30-90 minutes after increase with 20% of vasoactive medication and haemodynamic stabilisation
Secondary Outcome Measure Information:
Title
Eadyn estimation on haemodynamic monitor
Description
display on the hemodynamic monitor
Time Frame
from 30 to 90 minutes after increase with 20% of vasoactive medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veerle Van Mossevelde, Datanurse
Phone
+32 2 476 31 34
Email
veerle.vanmossevelde@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Annelies De Cock, Datanurse
Phone
+32 2 474 99 06
Email
annelies.decock@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Poelaert, PhD, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel Vervoort, IR
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Chair
Facility Information:
Facility Name
universitair Ziekenhuis Brussel
City
Jette
State/Province
Vlaams Brabant
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veerle Van Mossevelde
Phone
+3224763134
Email
veerle.vanmossevelde@uzbrussel.be
12. IPD Sharing Statement
Learn more about this trial
Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.
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