Focused Assessed Echocardiography to Predict Fluid Responsiveness

NCT03044405 | Completed

• 1 other identifier: ECHO2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of the study are:

1. 1.To evaluate the feasibility of echocardiography monitoring in postoperative unit;
2. 2.To assess diagnostic value of different focussed echocardiography parameters to define fluid responsiveness for non-cardiac hypotensive spontaneously breathing patients after major abdominal surgery.

Conditions

Hypovolemia; Surgery; Hypotension

Keywords

fluid responsiveness; focused echocardiography; major surgery

Outcome Measures

Primary Outcomes (1)

• All hypotensive patients are divided into responders and non-responders according to increase of left ventricle outflow tract velocity time integral (LVOT VTI) after fluid challenge.

  Fluid challenge - fluid bolus of 500 ml of crystalloids which is given over 15 minutes. Positive fluid responsiveness is defined by an increase in stroke volume of at least 15%. Measurements are taken before and immediately after fluid challenge.

  the first hour after the surgery

Secondary Outcomes (7)

• The frequency of fluid responsiveness defined by clinical signs and focused transthoracic echocardiography data after fluid challenge is compared.

  the first hour after the surgery

• Mitral E wave velocity (cm/s) is compared between responders and non-responders.

  the first hour after the surgery

• E/A ratio is compared between responders and non-responders.

  the first hour after the surgery

• Variability of LVOT VTI (%) during breathing cycles is compared between responders and non-responders.

  the first hour after the surgery

• Cardiac index (L/min/m2) is compared between responders and non-responders.

  the first hour after the surgery

Study Arms (1)

Responders and non-responders

OTHER

Fluid challenge of 500 ml of crystalloids over 15 minutes is given. Positive fluid responsiveness is defined by an increase in stroke volume (SV) of at least 15% assessed by focused transthoracic echocardiography.

Diagnostic Test: Fluid challenge; Diagnostic Test: Focused transthoracic echocardiography

Interventions

Fluid challenge DIAGNOSTIC_TEST

Fluid bolus of 500 ml of crystalloids is given over 15 minutes. Positive fluid responsiveness is defined by an increase in SV of at least 15%.

Responders and non-responders

Focused transthoracic echocardiography DIAGNOSTIC_TEST

Focused transthoracic echocardiography is performed to assess expansion of stroke volume after fluid challenge. Also mitral E and A waves, left ventricle outflow tract velocity time integral (LVOT VTI) and its variability, inferior vena cava diameters during breathing cycles are measured.

Also known as: extended hemodynamic monitoring

Responders and non-responders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years old.
• Patients who sign an agreement form to participate in the study.
• Patients undergoing major abdominal surgery.
• Hypotension

You may not qualify if:

• Younger than 18 years old.
• Known pregnancy.
• Unconscious patients or those who do not agree to participate in the study.
• Urgent surgery.
• Normal arterial blood pressure.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

MeSH Terms

Conditions

Hypovolemia; Hypotension

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Asta Maciuliene, M.D.

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Andrius Macas, profesor

  Lithuanian University of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients who had reduced arterial blood pressure up to 30% from the baseline after major abdominal surgery (gastric resection, gastrectomy, liver resection, pancreatic-duodenal resection, colorectal surgery) were included in the study.

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 7, 2017
• Study Start: May 1, 2016
• Primary Completion: August 23, 2016
• Study Completion: September 1, 2016
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share