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
About this trial
This is an interventional diagnostic trial for Hypovolemia focused on measuring fluid responsiveness, focused echocardiography, major surgery
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.
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
NCT ID
NCT03044405
First Posted
January 26, 2017
Last Updated
February 2, 2017
Sponsor
Lithuanian University of Health Sciences
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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