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

Mahidol University

Status: Enrolling

Conditions: Shock; Septic Shock

Treatments: Diagnostic Test: Left ventricular diastolic function; Diagnostic Test: Inferior vena cava variation

Study type: Interventional

Funder types: Other

Identifiers

NCT05066256

Si 752/2020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Fluid responsive test

Experimental group

Description:

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

Treatment:

Diagnostic Test: Inferior vena cava variation

Diagnostic Test: Left ventricular diastolic function