Diastolic dYsfunctioN AssessMent in critICally Ill Patients (DYNAMIC)

December 13, 2021 updated by: Humanitas Clinical and Research Center

Diastolic dYsfunctioN AssessMent in critICally Ill Patients: an Observational Prospective Multicentric Study.

The role of the left ventricular diastolic function (LVDD) in the weaning failure from mechanical ventilation in unclear. Specifically, is unclear whether the outcome of the weaning process could be affected by a pre-existing LVDD (before ICU admission), or by the worsening of a chronic pattern, or by a de-novo LVDD presentation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Bedside echocardiography plays a critical diagnostic role in patients with heart failure, being other examinations (i.e., physical examination, electrocardiogram, and chest radiograph) unable to provide key information to discriminate between diastolic and systolic heart failure. Transthoracic echocardiography (TTE) can assess diastolic function by means of the doppler filling pattern, and can non-invasively measure intracardiac pressure at the bedside.

During sinus rhythm, diastolic flow shows the E and A waves, which reflects early diastolic filling and atrial contraction in the late diastole, respectively. Velocity of blood flow across the mitral valve depends on the trans-mitral pressure gradient; then, E-wave velocity is influenced both by the rate of early diastolic relaxation and by the left atrial pressure. Changes of the velocity pattern can suggest left ventricular diastolic function (LVDD) and prognosis, although mitral inflow patterns are highly susceptible to loading conditions (mainly left atrial pressure). LVDD is quite is a condition quite common in the population. A cross-sectional survey of over 2000 randomly selected Minnesota residents aged 45 years or older found an incidence of LVDD almost five times higher than LV systolic dysfunction (28% vs. 6%, respectively), which was a strong predictor of mortality (hazard ratio ranging from 8.3 for mild LVDD to 10.2 for at-least-moderate LVDD).

In a randomly recruited population sample (n = 539; 50.5% women; mean age, 52.5 years), the prevalence of the LVDD in those patients older than 50 y.o. was of about 50%5.

Doppler echocardiography could be a noninvasive tool for the detection of weaning-induced left ventricular filling pressure elevation. Transmitral flow can help measure peak Doppler velocities of E and A waves. E/A ratio has been proposed to estimate the left ventricular filling pressure. Tissue Doppler imaging can measure early diastolic mitral annular velocity (E'), which is a load-independent indicator of myocardial relaxation. The combination of tissue Doppler imaging and pulsed Doppler transmitral flow can allow the computation of the E/E' ratio, which is one of the best echocardiographic estimate of left ventricular filling pressure.

The role of LVDD in critically ill patients is probably greatly underestimated by intensivists, probably because in the past diastolic function was difficult to evaluate at the bedside6. The LVDD in intensive care unit (ICU) patients can affect the outcome of weaning from mechanical ventilation, especially in septic patients. In fact, cardiogenic pulmonary edema has been recognized as a highly incident cause of weaning failure. Unsuccessful weaning from mechanical ventilation occurs in approximately 20% of patients and is related to prolonged mechanical ventilation, length of stay in the intensive care unit, and increased morbidity and mortality. It has been proved that a spontaneous breathing trial (SBT) increases the left ventricular filling pressure, leading to cardiogenic pulmonary edema and impaired gas exchange.

However, studies focused on the impact of that medical condition on weaning showed conflicting results. Moreover, heterogeneous definitions and measurements of LVDD have been provided, associated to different form of SBTs. Furthermore, the majority carried out a cross-sectional assessment of the LVDD before and after the SBT, not including changes in the diastolic function during the ICU stay. All these variables limit the comparability and the clinical applications of these studies.

Moreover, LV diastolic function depends on myocardial relaxation, LV stiffness, and filling pressures, which are frequently impaired during the ICU stay (e.g., progression of the disease, volume resuscitation, positive end-expiratory pressure, administration of inotropes, vasopressors, etc). It is still uncertain whether the SBT failure could be affected by pre-existing conditions (i.e. a LVDD present at the ICU admission) or by a worsening of the cardiac function after the ICU admission.

As a matter of fact, the assessment of LVDD at the bedside is not routinely performed before the SBT and the role of the degree of the LVDD in still not defined. Moreover, it unclear whether the outcome of the weaning process could be affected by a pre-existing LVDD (before ICU admission), or by the worsening of a chronic pattern, or by a de-novo LVDD presentation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy
        • Not yet recruiting
        • "Policlinico-San Marco"
        • Contact:
          • Filippo Sanfilippo
      • Perugia, Italy
        • Not yet recruiting
        • Azienda Ospedaliera di Perugia
        • Contact:
          • Gianmaria Cammarota
      • Reggio Calabria, Italy
        • Not yet recruiting
        • Grande Ospedale Metropolitano
        • Contact:
          • Marco Tescione
      • Roma, Italy
        • Not yet recruiting
        • Policlinico Universitario A. Gemelli
        • Contact:
          • Antonio Dell'anna
      • Udine, Italy
        • Not yet recruiting
        • Azienda Sanitaria Universitaria integrata di Udine
        • Contact:
          • Luigi Vetrugno
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • HUMANITAS Research Hospital
    • Novara
      • Borgomanero, Novara, Italy, 28100
        • Not yet recruiting
        • Ospedale SS. Trinità
        • Contact:
          • DAvide Colombo
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Not yet recruiting
        • Careggi University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients admitted to General ICU

Description

Inclusion criteria:

  • Expected to be ventilated for >48 hours
  • Age > 50

Exclusion criteria:

  • Atrial fibrillation (at the admission or during ICU stay);

  • Neuromuscular disorders

    •. Severe neurological events (traumatic or not) with GCS < 8 at admission

  • Home ventilation prior to admission;
  • Palliative intubation;
  • Intubation for an indication to tracheostomy;
  • Poor acoustic window (after the first assessment);
  • Severe mitral and/or aortic valve stenosis or regurgitation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Spontaneous breathing trial failure
Time Frame: 6 hour after Spontaneous breathing trial end
Patients admitted with LVDD
6 hour after Spontaneous breathing trial end
Spontaneous breathing trial failure
Time Frame: 6 hour after Spontaneous breathing trial end
Patients worsening a pre-existing LVDD or developing a LVDD during the ICU stay.
6 hour after Spontaneous breathing trial end

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of LVDD in critically ill patients
Time Frame: up to 3 weeks
Echocardiography measurements
up to 3 weeks
To assess the degree of the LVDD in critically ill patients
Time Frame: up to 3 weeks
Echocardiography measurements
up to 3 weeks
To correlate LVDD with clinical outcomes
Time Frame: up to 3 weeks
Echocardiography measurements
up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Humanitas Clinical and Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antonio Messina, PhD, Humanitas Mirasole SpA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dynamic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Raw data available from the PI, under reasonable reason

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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