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

NCT05066256 | Unknown

• 1 other identifier: Si 752/2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock; Septic Shock

Keywords

shock; fluid responsiveness; left ventricular diastolic dysfunction; Mitral E/e'

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fluid responsive test

EXPERIMENTAL

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; Diagnostic Test: Inferior vena cava variation

Interventions

Left ventricular diastolic function DIAGNOSTIC_TEST

Transthoracic echocardiography Mitral E/e'

Also known as: Mitral E/e'

Fluid responsive test

Inferior vena cava variation DIAGNOSTIC_TEST

Inferior vena cava variation from ultrasound

Also known as: IVC variation

Fluid responsive test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Shock; Shock, Septic; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Surat Tongyoo

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Surat Tongyoo

CONTACT

6624198534; surat.ton@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-experimental study

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: September 22, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Within 6 months after study publication
• Access Criteria: Request to principal investigator after ethical committee approval

Locations

TH (1)