Focused Assessed Echocardiography to Predict Fluid Responsiveness

Surgery Clinical Trial

— fluidres  

Official title:

Focused Assessed Echocardiography to Predict Fluid Responsiveness for Non-cardiac Hypotensive Spontaneously Breathing Patients After Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044405
• Other study ID #: ECHO2
• Status: Completed
• Phase: N/A
• First received: January 26, 2017
• Last updated: February 2, 2017
• Start date: May 1, 2016
• Est. completion date: September 1, 2016

Study information

• Verified date: February 2017
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of the study are:

1. To evaluate the feasibility of echocardiography monitoring in postoperative unit;

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.

Description:

As there are different strategies of perioperative fluid management discussion which is the choice liberal or restrictive one occurs? Individualized infusion therapy should be the goal. The investigators hypothesize extended hemodynamic monitoring based on focused transthoracic echocardiography enable to differentiate the cause of hypotension more carefully and fluid overload will be avoided after major abdominal surgery.

The goals of the study are:

• To conduct one group of hypotensive patients after major abdominal surgery. To divide this group into responders and nonresponders after fluid challenge.

• To evaluate the feasibility of echocardiography monitoring in postoperative unit (having in mind such restrains as supine position, postoperative pain, bandages etc.)

• To compare the evaluation of fluid responsiveness by clinical signs and focused assessed echocardiography data.

• To identify the best focused echocardiography parameters for prognosis of fluid responsiveness.

• To determine if extended hemodynamic monitoring changes postoperative fluid management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2016
• Est. primary completion date: August 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age more than 18 years old.

• Patients who sign an agreement form to participate in the study.

• Patients undergoing major abdominal surgery.

• Hypotension

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hypotension
• Hypovolemia
• Surgery

Intervention

Diagnostic Test:
• Fluid challenge
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%.
• Focused transthoracic echocardiography
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The frequency of fluid responsiveness defined by clinical signs and focused transthoracic echocardiography data after fluid challenge is compared.	Positive fluid responsiveness by clinical signs is defined as increase of arterial blood pressure more than 10mmHg after fluid challenge.; Positive fluid responsiveness by focused transthoracic echocardiography data is defined as increase of LVOT VTI more than 15%.	the first hour after the surgery
Secondary	Mitral E wave velocity (cm/s) is compared between responders and non-responders.	Measurement is taken before the fluid challenge. The most reliable parameters to predict fluid responsiveness for non-cardiac hypotensive, spontaneously breathing patients after major abdominal surgery are assessed. The area under the curve (AUC) is defined to be clinically relevant if AUC is more than 0.7.	the first hour after the surgery
Secondary	E/A ratio is compared between responders and non-responders.	Measurement is taken before the fluid challenge. The most reliable parameters to predict fluid responsiveness for non-cardiac hypotensive, spontaneously breathing patients after major abdominal surgery are assessed. The area under the curve (AUC) is defined to be clinically relevant if AUC is more than 0.7.	the first hour after the surgery
Secondary	Variability of LVOT VTI (%) during breathing cycles is compared between responders and non-responders.	Measurement is taken before the fluid challenge. The most reliable parameters to predict fluid responsiveness for non-cardiac hypotensive, spontaneously breathing patients after major abdominal surgery are assessed. The area under the curve (AUC) is defined to be clinically relevant if AUC is more than 0.7.	the first hour after the surgery
Secondary	Cardiac index (L/min/m2) is compared between responders and non-responders.	Measurement is taken before the fluid challenge. The most reliable parameters to predict fluid responsiveness for non-cardiac hypotensive, spontaneously breathing patients after major abdominal surgery are assessed. The area under the curve (AUC) is defined to be clinically relevant if AUC is more than 0.7.	the first hour after the surgery
Secondary	Variability of inferior vena cava (%) is compared between responders and non-responders.	Measurement is taken before the fluid challenge.The most reliable parameters to predict fluid responsiveness for non-cardiac hypotensive, spontaneously breathing patients after major abdominal surgery are assessed. The area under the curve (AUC) is defined to be clinically relevant if AUC is more than 0.7.	the first hour after the surgery
Secondary	The planed infusion therapy before and after evaluation by focused transthoracic echocardiography is compared in responders and non-responders.		the first 24 hours after the surgery