Clinical trial NCT03044405: Focused Assessed Echocardiography to Predict Fluid Responsiveness
Official title: Focused Assessed Echocardiography to Predict Fluid Responsiveness for Non-cardiac Hypotensive Spontaneously Breathing Patients After Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypovolemia
Surgery
Hypotension
Keywords: fluid responsiveness
focused echocardiography
major surgery
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: 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.
timeFrame: the first hour after the surgery
Secondary outcomes:
measure: The frequency of fluid responsiveness defined by clinical signs and focused transthoracic echocardiography data after fluid challenge is compared.
timeFrame: the first hour after the surgery
measure: Mitral E wave velocity (cm/s) is compared between responders and non-responders.
timeFrame: the first hour after the surgery
measure: E/A ratio is compared between responders and non-responders.
timeFrame: the first hour after the surgery
measure: Variability of LVOT VTI (%) during breathing cycles is compared between responders and non-responders.
timeFrame: the first hour after the surgery
measure: Cardiac index (L/min/m2) is compared between responders and non-responders.
timeFrame: the first hour after the surgery
measure: Variability of inferior vena cava (%) is compared between responders and non-responders.
timeFrame: the first hour after the surgery
measure: The planed infusion therapy before and after evaluation by focused transthoracic echocardiography is compared in responders and non-responders.
timeFrame: the first 24 hours after the surgery
Other outcomes:
Locations:
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Asta Maciuliene, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lithuanian University of Health Sciences
name: Andrius Macas, profesor
role: STUDY_CHAIR
References: