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

Septic Shock Clinical Trial

Official title:

Left Ventricular Diastolic Function Compare to Inferior Vena Cava Diameter Variation as Predictor of Fluid Responsiveness in Mechanical Ventilated Patients With Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05066256
• Other study ID #: Si 752/2020
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: September 2024

Study information

• Verified date: September 2021
• Source: Mahidol University
• Contact: Surat Tongyoo
• Phone: 6624198534
• Email: surat.ton[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock

Intervention

Diagnostic Test:
• Left ventricular diastolic function
Transthoracic echocardiography Mitral E/e'
• Inferior vena cava variation
Inferior vena cava variation from ultrasound

Locations

Country	Name	City	State
Thailand	Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid responsiveness	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.	6 hours