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

Not Applicable

Recruiting

• Conditions: Shock; Septic Shock
• Interventions: Diagnostic Test: Left ventricular diastolic function; Diagnostic Test: Inferior vena cava variation

• Registration Number: NCT05066256
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-22
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Study First Posted: 2021-10-04
• Last Update Posted: 2021-10-04
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluid responsive test	Left ventricular diastolic function	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
Fluid responsive test	Inferior vena cava variation	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

Primary Outcome Measures

Name	Time	Method
Fluid responsiveness	6 hours	Fluid responsiveness defined by increase in cardiac output at least 15% or increase in systolic blood pressure at least 10 mmHg or increase in mean arterial pressure at least 5 mmHg.

Trial Locations

Locations (1)

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand