LV Diastolic Function vs IVC Diameter Variation as Predic... | NCT05066256

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

NCT05066256

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Oct 4, 2021Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Shock
Septic Shock

Interventions

Left ventricular diastolic function
Inferior vena cava variation

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2021Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Sep 23, 2021

First Submission Date that Met QC Criteria

Oct 1, 2021

First Posted Date

Oct 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2021

Last Update Posted Date

Oct 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Left ventricular diastolic function	Diagnostic Test	Transthoracic echocardiography Mitral E/e'	Fluid responsive test

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Surat Tongyoo	Contact	6624198534		surat.ton@mahidol.ac.th

Overall Officials

Name	Affiliation	Role
Surat Tongyoo	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University	Recruiting	Bangkok		10700	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymus participant data will be available after request with ethical committee approval.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Within 6 months after study publication

Access Criteria

Request to principal investigator after ethical committee approval

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012769	Shock
D012772	Shock, Septic
D018487	Ventricular Dysfunction, Left

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D018805	Sepsis
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided