Arterial Tone Influence on Cardiac Output Measured by PRAM | NCT03900546

Studies
Arterial Tone Influence on Cardiac Output Measured by PRAM

NCT03900546

Sponsor

Università Politecnica delle Marche

Status

Completed

Last Update Posted

Mar 25, 2020Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Cardiac Output
Critically Ill

Interventions

MostCare

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014Actual

Primary Completion Date

Feb 2020Actual

Completion Date

Feb 2020Actual

First Submitted Date

Mar 29, 2019

First Submission Date that Met QC Criteria

Apr 2, 2019

First Posted Date

Apr 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2020

Last Update Posted Date

Mar 25, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abele Donati, MD, Professor, Università Politecnica delle MarchePrincipal Investigator

Lead Sponsor

Università Politecnica delle MarcheOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the role of arterial tone in the accuracy of cardiac output (CO) measurement by Pressure Recording Analytical Method (PRAM). Patients receiving noradrenaline who need for clinical reason to change the noradrenaline dose will be enrolled. We use echocardiography as reference method of CO measurement.

Detailed Description

Pressure Recording Analytical Method (PRAM) is an arterial pulse contour analysis method for CO measurement. As it is an uncalibrated method, one possible reason for its inaccuracy is rapid changes in arterial tone.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MostCare	Device	CO measurement using echocardiography and PRAM before and after noradrenaline dose change due to clinical reason

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of cardiac output after variation of noradrenaline dose: ECO versus PRAM	Agreement between echocardiography and PRAM in CO measurement during arterial tone changes induced by different dose of noradrenaline	Before and 30 minutes after noradrenaline dose variation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

invasive blood pressure monitoring on site
need to start or change the dose of noradrenaline infusion for clinical reason

Exclusion Criteria:

age <18
arrhythmia
severe valvular insufficiency
pregnancy
low quality arterial signal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients admitted to intensive care unit that need variation of noradrenaline dose for clinical reason.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abele Donati, MD, PhD	Università Politecnica delle Marche	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona		Ancona			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will not be shared with other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided