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Clinical Trials/NCT03044405
NCT03044405
Completed
Not Applicable

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

Lithuanian University of Health Sciences0 sites40 target enrollmentMay 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypovolemia
Sponsor
Lithuanian University of Health Sciences
Enrollment
40
Primary Endpoint
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.
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2016
End Date
September 1, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asta Maculiene

Principal Investigator

Lithuanian University of Health Sciences

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Time Frame: the first hour after the surgery

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.

Secondary Outcomes

  • 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)
  • Variability of inferior vena cava (%) is compared between responders and non-responders.(the first hour after the surgery)
  • 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)

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