Clinical trial NCT05066256: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Shock
Septic Shock
Keywords: shock
fluid responsiveness
left ventricular diastolic dysfunction
Mitral E/e'
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-experimental study
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Fluid responsiveness
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Surat Tongyoo
role: PRINCIPAL_INVESTIGATOR
References: