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Focused Assessed Echocardiography to Predict Fluid Responsiveness (fluidres)

Primary Purpose

Hypovolemia, Surgery, Hypotension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluid challenge
Focused transthoracic echocardiography
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypovolemia focused on measuring fluid responsiveness, focused echocardiography, major surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Responders and non-responders

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 26, 2017
    Last Updated
    February 2, 2017
    Sponsor
    Lithuanian University of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03044405
    Brief Title
    Focused Assessed Echocardiography to Predict Fluid Responsiveness
    Acronym
    fluidres
    Official Title
    Focused Assessed Echocardiography to Predict Fluid Responsiveness for Non-cardiac Hypotensive Spontaneously Breathing Patients After Major Abdominal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2016 (Actual)
    Primary Completion Date
    August 23, 2016 (Actual)
    Study Completion Date
    September 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lithuanian University of Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aims of the study are: To evaluate the feasibility of echocardiography monitoring in postoperative unit; 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypovolemia, Surgery, Hypotension
    Keywords
    fluid responsiveness, focused echocardiography, major surgery

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Responders and non-responders
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Fluid challenge
    Intervention Description
    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%.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Focused transthoracic echocardiography
    Other Intervention Name(s)
    extended hemodynamic monitoring
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    the first hour after the surgery
    Secondary Outcome Measure Information:
    Title
    The frequency of fluid responsiveness defined by clinical signs and focused transthoracic echocardiography data after fluid challenge is compared.
    Description
    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%.
    Time Frame
    the first hour after the surgery
    Title
    Mitral E wave velocity (cm/s) is compared between responders and non-responders.
    Description
    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.
    Time Frame
    the first hour after the surgery
    Title
    E/A ratio is compared between responders and non-responders.
    Description
    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.
    Time Frame
    the first hour after the surgery
    Title
    Variability of LVOT VTI (%) during breathing cycles is compared between responders and non-responders.
    Description
    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.
    Time Frame
    the first hour after the surgery
    Title
    Cardiac index (L/min/m2) is compared between responders and non-responders.
    Description
    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.
    Time Frame
    the first hour after the surgery
    Title
    Variability of inferior vena cava (%) is compared between responders and non-responders.
    Description
    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.
    Time Frame
    the first hour after the surgery
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Asta Maciuliene, M.D.
    Organizational Affiliation
    Lithuanian University of Health Sciences
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Andrius Macas, profesor
    Organizational Affiliation
    Lithuanian University of Health Sciences
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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