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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Shock; Septic Shock
• Intervention / Treatment: Diagnostic test: Left ventricular diastolic function; Diagnostic test: Inferior vena cava variation

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Surat Tongyoo; Phone Number: 6624198534; Email: surat.ton@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Diagnostic test: Left ventricular diastolic function; Transthoracic echocardiography Mitral E/e'; Other Names: Mitral E/e'; Diagnostic test: Inferior vena cava variation; Inferior vena cava variation from ultrasound; Other Names: IVC variation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Surat Tongyoo, Mahidol University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 22, 2021
• Primary Completion (ANTICIPATED): September 1, 2024
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (ACTUAL): October 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: shock; fluid responsiveness; left ventricular diastolic dysfunction; Mitral E/e'
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: Si 752/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymus participant data will be available after request with ethical committee approval.
• IPD Sharing Time Frame: Within 6 months after study publication
• IPD Sharing Access Criteria: Request to principal investigator after ethical committee approval
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No