HypovolemiafluidresNCT03044405
Focused Assessed Echocardiography to Predict Fluid Responsiveness
A study testing Fluid challenge and Focused transthoracic echocardiography in people with Hypovolemia and Surgery, run by Lithuanian University of Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypovolemia, Surgery, Hypotension
- What is being tested?
- Fluid challenge and Focused transthoracic echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 1 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age more than 18 years old.
- Patients who sign an agreement form to participate in the study.
- Patients undergoing major abdominal surgery.
- Hypotension
Who cannot join
- 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.
About this study
Official title: Focused Assessed Echocardiography to Predict Fluid Responsiveness for Non-cardiac Hypotensive Spontaneously Breathing Patients After Major Abdominal Surgery
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.
Read the 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.
- Conditions
- Hypovolemia, Surgery, Hypotension
- Being tested
- Fluid challenge, Focused transthoracic echocardiography
- Keywords
- fluid responsiveness, focused echocardiography, major surgery
- Medical subject headings
- Hypovolemia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challengeDiagnostic 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 echocardiographyDiagnostic test
Also called extended hemodynamic monitoring
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.
| Study group | Role | What they receive |
|---|---|---|
| Responders and non-responders | Other | 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. Receives: Diagnostic Test: Fluid challenge; Diagnostic Test: Focused transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the first hour after the surgery
Secondary outcomes (7)
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%.
Measured: the first hour after the surgery
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.
Measured: the first hour after the surgery
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.
Measured: the first hour after the surgery
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.
Measured: the first hour after the surgery
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.
Measured: the first hour after the surgery
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.
Measured: the first hour after the surgery
The planed infusion therapy before and after evaluation by focused transthoracic echocardiography is compared in responders and non-responders.
Measured: the first 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 May 2016
- Primary completion23 Aug 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asta Maculiene, Lithuanian University of Health Sciences
- Investigators
- Asta Maciuliene, M.D., Principal investigator, Lithuanian University of Health SciencesAndrius Macas, profesor, Study chair, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044405
- Sponsor's protocol ID
- ECHO2
- Acronym
- fluidres
- Status last verified
- Feb 2017
- First submitted
- 26 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Assessed Echocardiography to Predict Fluid Responsiveness for Non-cardiac Hypotensive Spontaneously Breathing Patients After Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03044405
- Acronym / sponsor ID
- fluidres / ECHO2
- Conditions
- Hypovolemia, Surgery, Hypotension
- Keywords
- fluid responsiveness, focused echocardiography, major surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 23 Aug 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Responders and non-responders | Other | Diagnostic Test: Fluid challenge, Diagnostic Test: Focused transthoracic echocardiographyFluid 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age more than 18 years old.
- Patients who sign an agreement form to participate in the study.
- Patients undergoing major abdominal surgery.
- Hypotension
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid challengeFluid 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 | Responders and non-responders |
| Focused transthoracic echocardiographyAlso: extended hemodynamic monitoringFocused 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. | Diagnostic test | Responders and non-responders |
Primary outcome
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.
7 secondary outcomes
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
Mitral E wave velocity (cm/s) is compared between responders and non-responders.
Time frame: the first hour after the surgery
E/A ratio is compared between responders and non-responders.
Time frame: the first hour after the surgery
Variability of LVOT VTI (%) during breathing cycles is compared between responders and non-responders.
Time frame: the first hour after the surgery
Cardiac index (L/min/m2) is compared between responders and non-responders.
Time frame: the first hour after the surgery
Variability of inferior vena cava (%) is compared between responders and non-responders.
Time frame: the first hour after the surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Hypovolemia
RecruitingPhase 4
A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients
Hypovolemic Shock
Not yet recruitingObservational study
Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock
Hemorrhagic Shock, Trauma
Not yet recruitingObservational study
Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring
Dehydration, Hypovolemia
RecruitingPhase 4
Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy
Fibroids, Uterine, Fluid Deficit
RecruitingObservational study
Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
Congenital Heart Disease (CHD), Univentricular Heart
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asta Maciuliene, M.D. principal investigator
Lithuanian University of Health Sciences
Andrius Macas, profesor study chair
Lithuanian University of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Fluid challenge and Focused transthoracic echocardiography in people with Hypovolemia and Surgery, run by Lithuanian University of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: the first hour after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.