LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock

NCT ID: NCT05066256

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-22

Study Completion Date

2024-09-30

Brief Summary

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Fluid responsive is defined as increasing in Cardiac output or Stroke volume by 10-15% after fluid challenge. Left ventricular diastolic dysfunction is associated with lower left ventricular end-diastolic volume (LVEDV) resulting in a less cardiac output increment after fluid challenge. However, Left ventricular diastolic function indicated by the Mitral E/e' ratio from transthoracic echocardiography, was rarely studied for fluid responsiveness evaluation.

Detailed Description

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Fluid therapy is one of the main treatments in patients with shock to increase Oxygen delivery by increasing Cardiac output or Stroke volume. However excess fluid intake may cause fluid overload, resulting in tissue edema, lung edema and organ dysfunction, which can lead to patient deterioration.

Fluid responsiveness, defined as increasing in Cardiac output or Stroke volume by 10-15% after fluid challenge, is being recommended to evaluate in-patients with shock, according to European Society of Intensive Care Medicine (ESICM). Cardiac output measurement is often invasive or requires an expensive device, therefore, tests for predicting fluid responsiveness have been used to substitute direct Cardiac output measurement.

Left ventricular diastolic dysfunction is associated with a decreasing Left ventricular end-diastolic volume, resulting in a less cardiac output increment after fluid challenge and can be measured by using Mitral E/e' ratio via transthoracic echocardiography.

Despite being a non-invasive test, the Mitral E/e' ratio obtained from Echocardiography was rarely studied for the prediction of fluid responsiveness.

Conditions

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Shock Septic Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre-experimental study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fluid responsive test

Measure cardiac output, inferior vena cava (IVC) diameter variation and LV diastolic function (E/e') baseline Fluid challenge Measure cardiac output, IVC diameter variation and LV diastolic function (E/e') after fluid challenge

Group Type EXPERIMENTAL

Left ventricular diastolic function

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiography Mitral E/e'

Inferior vena cava variation

Intervention Type DIAGNOSTIC_TEST

Inferior vena cava variation from ultrasound

Interventions

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Left ventricular diastolic function

Transthoracic echocardiography Mitral E/e'

Intervention Type DIAGNOSTIC_TEST

Inferior vena cava variation

Inferior vena cava variation from ultrasound

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Mitral E/e' IVC variation

Eligibility Criteria

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Inclusion Criteria

* Age more than 18 years
* Diagnosis of shock defined by systolic blood pressure \< 90 mmHg or mean arterial blood pressure \< 65 mmHg and/or clinical hypoperfusion
* Mechanically ventilated without ventilator dyssynchrony and no ventilator triggering
* Present of central venous cather or arterial catheter

Exclusion Criteria

* Age \< 18 years
* Frankly hypovolemic shock or hemorrhagic shock
* Suspicious of cardiogenic shock
* Suspicious of acute decompensated heart failure
* Suspicious of acute coronary syndrome
* Denied participation or denied inform consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Surat Tongyoo

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Surat Tongyoo

Role: CONTACT

6624198534

Facility Contacts

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Surat Tongyoo, MD

Role: primary

6624198534

Other Identifiers

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Si 752/2020

Identifier Type: -

Identifier Source: org_study_id

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