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Acute Respiratory Distress SyndromeNCT03920189

Echocardiographic Evaluation in ARDS Patients

An observational study of Acute Respiratory Distress Syndrome and Mechanical Ventilation, run by University of Milan at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the left diastolic function at different levels of in patients affected by the acute respiratory distress syndrome (ARDS) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
echocariographic ultrasound
How many people
44 participants
Where
1 siteItaly
Study dates
1 Sep 2018to 1 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: consecutive ARDS patients

Who may be able to join

  • All patients aged 18 or older and with a recent (<48h) diagnosis of ARDS, undergoing invasive mechanical ventilation

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • ASST-Santi Paolo e Carlo, San Paolo Hospital

    Milan, 20142

Other trials in Italy

About this study

Official title: Left Diastolic Function in ARDS Mechanically Ventilated Patients

The purpose of this study is to assess the left diastolic function at different levels of in patients affected by the acute respiratory distress syndrome (ARDS)

Read the detailed description

Introduction Left ventricular diastolic dysfunction (DD) is a clinical entity that remains poorly understood and identified in the intensive care unit (ICU) setting. In general, it is a syndrome defined by the presence of symptoms of congestive heart failure without sign of reduced left ventricle systolic dysfunction. Distinguishing diastolic heart failure from systolic heart failure is important because of differences in treatment and prognosis, even if often the two entities coexist, and some authors have proposed the hypothesis that diastolic LV dysfunction is essentially a precursor of systolic failure. At the base on DD there are multiple causes and multiple disorders. Among these, the impaired relaxation (common in ischemia and during systemic inflammatory states), an impaired peak left ventricular (LV) filling rate (with inadequate trans-mitral pressure gradient due to raised LV pressure or inability to generate negative LV pressure), the stiffness of LV (fibrosis and hypertrophy), and constriction (pericardial or compression from dilated right ventricle). Diastolic LV dysfunction is common in the ICU but often unrecognized. Its knowledge and determination of its severity may be useful to optimize circulatory support in critically ill patients. From this point of view, echocardiography is one of the most powerful diagnostic and monitoring tools available, providing the means to diagnose cardiac systolic or diastolic dysfunction, its underlying cause, and suggest therapeutic interventions. The aim of this study is to describe the presence and the grade of the eventually left diastolic dysfunction in ARDS patients and its possible correlation with the severity of illness and outcome.

Definitions and pathophysiology Diastolic heart failure is defined as a condition caused by increased resistance to the filling of one or both ventricles; this leads to symptoms of congestion from the inappropriate upward shift of the diastolic pressure-volume relation. Although this definition describes the principal pathophysiologic mechanism of diastolic heart failure, it is not clinically applicable. In a more practical definition diastolic heart failure is a condition that includes classic congestive heart failure findings with normal systolic function at rest, but with alteration in diastolic function. During DD the combination of active relaxation and passive myocardial compliance that normally maintain an adequate cardiac output are altered and left atrial pressure should be increased to maintain a satisfactory cardiac output. Different parameters have been used over the past two decades to describe the DD, so it is difficult to define its real incidence in critically ill patients. It seems to occur in about 30% of cases, and the majority of the studies tend to relate it with concomitant syndrome such as sepsis or clinical conditions such as respiratory weaning failure.

Left Diastolic dysfunction in ICU Most of the literature available investigated left DD in septic patient, and even if in the majority of these studies the patients were mechanically ventilated, only few information are available about the role of mechanical ventilation (MV) or the acute phase of lung injury.

With The advent of tissue Doppler imaging (TDI) has simplified echocardiographic estimation of ventricular relaxation and ventricular filling pressures, and the increasing number of studies in the field have showed that diastolic dysfunction is common in critically ill patients. The significance of diastolic dysfunction was recently highlighted by studies that demonstrated that TDI parameters might be prognostically useful in ICU population. More recent observations may help to clarify the scenario in these terms. An alteration in the E/e' ratio has been described in patients with septic shock and, although one study found that the E/e' ratio is an independent predictor of mortality [20], another investigation failed to find this association.

Left diastolic dysfunction in mechanical ventilated and ARDS patients It is well known that mechanical ventilation can induce hemodynamic compromise and that myocardial dysfunction and its consequences are not properly reflected by conventional hemodynamic parameters. Myocardial function can be assessed at the bedside using transthoracic echocardiography (TTE); however, the 2D echocardiographic measurements have been used to investigate predominantly the effects on systolic rather than diastolic ventricular function. Recently, TDI has provided more load-independent parameters to assess cardiac function, but its use is not widespread in ICU. For these reasons and probably because DD is greatly underestimated, there are few paper focused on mechanical ventilation and DD, most of them during weaning period, and almost none during the acute phase. What we know is that positive pressure ventilation can affect preload, afterload and ventricular compliance. The net effect in most situations is a decrease in cardiac output. However, the effect may be beneficial in the context of decompensated heart failure, where the decreased preload and afterload result in a return to a more productive part of the Starling curve.

More it is known in patients with prolonged weaning time. In this scenario, isolated diastolic dysfunction is present in about 22% up to 39% of patients. The increase in preload and afterload during MV may impair the LV compliance and determine a pulmonary edema. The fall in LV pressure during relaxation phase is a key determinant of diastolic function, and depends on intrinsic (contractility, LV stiffness) and extrinsic (preload, afterload) factors. Recently, has been suggested how the LV relaxation impairment with increased filling pressures may be a key mechanism of failed prolonged weaning trials. To summarize all these evidence, we could state that the elimination of positive ventilation increases LV preload and afterload and may induce some physiologic changes that can determine tachycardia and hypertension. Those are coincidentally two major determinants of diastolic dysfunction, as higher heart frequency reduces diastolic filling time and/or decreases coronary perfusion, and hypertension can exacerbate heart failure in patients with preserved ejection fraction. These findings suggest that echocardiography could be an excellent tool to guide the weaning process, helping to decide the best therapy to accomplish it.

Methods Consecutive mechanically ventilated patients will be enrolled within 48 hours after ICU admission with the diagnosis of ARDS. Demographic characteristics and respiratory mechanics variables (including esophageal pressure) will be recorded at two levels of positive end-expiratory pressure (PEEP); all patients will be study by a CT analysis at two levels of PEEP (5-45 cmh20) for the evaluation of recruitment potential, together with the computation of functional residual capacity (FRC). A well-trained cardiologist will perform a completed transthoracic echocardiography with the aim to describe the presence and the grade of left ventricular diastolic dysfunction (LVDD) applying a simplified definition of left DD, based on septal e', which is considered to be an index of myocardial relaxation, and the ratio of early diastolic velocity of mitral inflow to mitral annular velocity (E/e'), which has a strong association with left atrial pressure.

Being tested
echocariographic ultrasound
Medical subject headings
Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • echocariographic ultrasoundDiagnostic test

    left ventricular diastolic function description

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. echocardiographic ultrasound

    left ventricular dyastolic function

    Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start1 Sep 2018
  3. Primary completion1 Sep 2021
  4. Study completion1 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03920189
Sponsor's protocol ID
ARDS-ECHO
Status last verified
Jun 2022
First submitted
16 Apr 2019
Last updated
24 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Distress Syndrome and Mechanical Ventilation, run by University of Milan at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

echocardiographic ultrasound (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.

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