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

Primary Purpose

Shock, Septic Shock

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Left ventricular diastolic function
Inferior vena cava variation
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Shock focused on measuring shock, fluid responsiveness, left ventricular diastolic dysfunction, Mitral E/e'

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluid responsive test

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2021
Last Updated
October 1, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT05066256
Brief Title
LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock
Official Title
Left Ventricular Diastolic Function Compare to Inferior Vena Cava Diameter Variation as Predictor of Fluid Responsiveness in Mechanical Ventilated Patients With Shock
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Septic Shock
Keywords
shock, fluid responsiveness, left ventricular diastolic dysfunction, Mitral E/e'

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-experimental study
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluid responsive test
Arm Type
Experimental
Arm 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
Intervention Type
Diagnostic Test
Intervention Name(s)
Left ventricular diastolic function
Other Intervention Name(s)
Mitral E/e'
Intervention Description
Transthoracic echocardiography Mitral E/e'
Intervention Type
Diagnostic Test
Intervention Name(s)
Inferior vena cava variation
Other Intervention Name(s)
IVC variation
Intervention Description
Inferior vena cava variation from ultrasound
Primary Outcome Measure Information:
Title
Fluid responsiveness
Description
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.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Surat Tongyoo
Phone
6624198534
Email
surat.ton@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surat Tongyoo
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surat Tongyoo, MD
Phone
6624198534
Email
surat_Ty@yahoo.co.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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

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