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Focused Assessed Echocardiography to Predict Fluid Responsiveness (fluidres)

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ClinicalTrials.gov Identifier: NCT03044405
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Asta Maculiene, Lithuanian University of Health Sciences

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.

Condition or disease Intervention/treatment Phase
Hypovolemia Surgery Hypotension Diagnostic Test: Fluid challenge Diagnostic Test: Focused transthoracic echocardiography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Focused Assessed Echocardiography to Predict Fluid Responsiveness for Non-cardiac Hypotensive Spontaneously Breathing Patients After Major Abdominal Surgery
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : August 23, 2016
Actual Study Completion Date : September 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Responders and non-responders
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.
Diagnostic Test: Fluid challenge
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%.

Diagnostic Test: Focused transthoracic echocardiography
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 Name: extended hemodynamic monitoring




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044405


Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
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Principal Investigator: Asta Maciuliene, M.D. Lithuanian University of Health Sciences
Study Chair: Andrius Macas, profesor Lithuanian University of Health Sciences

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Responsible Party: Asta Maculiene, Principal Investigator, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT03044405    
Other Study ID Numbers: ECHO2
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asta Maculiene, Lithuanian University of Health Sciences:
fluid responsiveness
focused echocardiography
major surgery
Additional relevant MeSH terms:
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Hypotension
Hypovolemia
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes