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OpenTrials
Completed

NCT Number: NCT03044405

Focused Assessed Echocardiography to Predict Fluid Responsiveness

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.

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Key information

Conditions

Hypovolemia Cardiovascular Diseases Hypotension Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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%.

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.

Other names: extended hemodynamic monitoring

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.

    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

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

    Time frame: the first hour after the surgery

    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%.

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

    Time frame: the first hour after the surgery

    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.

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

    Time frame: the first hour after the surgery

    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.

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

    Time frame: the first hour after the surgery

    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.

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

    Time frame: the first hour after the surgery

    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.

  6. Variability of inferior vena cava (%) is compared between responders and non-responders.

    Time frame: the first hour after the surgery

    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.

  7. The planed infusion therapy before and after evaluation by focused transthoracic echocardiography is compared in responders and non-responders.

    Time frame: the first 24 hours after the surgery

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Acronym: fluidres

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 7, 2017
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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