NCT03900546

Completed

Arterial Tone Influence on Cardiac Output Measured by PRAM

Università Politecnica delle Marche Source

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Other study identifiers

Sponsor study identifier

PRAM

Study Type

observational

Actual enrollment (reported)

31

Locations

1 country

Sites

1

Timeline

Study Start

March 2014

Actual (reported)

Primary Completion

February 2020

Actual (reported)

Study Completion

February 2020

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 31 participants
Study completion date: February 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2014
Actual (reported)
First Submitted
March 29, 2019
Actual (reported)
First Posted
April 3, 2019
Actual (reported)
Primary Completion
February 2020
Actual (reported)
Study Completion
February 2020
Actual (reported)

Last Updated: March 25, 2020
Status Verified: March 2020
Last Update Submitted: March 23, 2020

Conditions

Cardiac Output Critically Ill

Outcome Measures

Primary Outcomes (1)

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

Interventions

MostCareDevice

CO measurement using echocardiography and PRAM before and after noradrenaline dose change due to clinical reason

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

invasive blood pressure monitoring on site

Sponsors & Collaborators

Università Politecnica delle Marche
Otherlead

Study Sites (1)

Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona

Ancona, Italy

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Abele Donati, MD, PhD
Università Politecnica delle Marche
PRINCIPAL INVESTIGATOR

Enrollment

31 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 3, 2019

Study Start

March 2014

Actual (reported)

Not ApplicableCompleted

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Not ApplicableCompleted

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European Mortality & Length Of Intensive Care Unit (ICU) Stay Evaluation (ELOISE)

Completed

NCT03970980

FIO2 Influences Accuracy of Fick-based Cardiac Output

Not ApplicableCompleted

NCT02330874

Validation of the SD-ICU. A Risk Assessment Tool of Unplanned ICU Readmission

Unknown

NCT03268967

Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)

Not ApplicableUnknown

need to start or change the dose of noradrenaline infusion for clinical reason

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

February 2020

Actual (reported)

Study Completion

February 2020

Actual (reported)

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing: Will not share

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT03900546
Data provider: ClinicalTrials.gov
Source updated: 2020-03-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:15 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations