Coronary Artery Bypass GraftingNCT04362033
Comparison of Dynamic Fluid Responsiveness by EIT and Transpulmonary Thermodilution in Postoperative of CABG Patients
A study testing Passive Leg Raising (PLR) and PEEP increment (PEEP) in people with Coronary Artery Bypass Grafting and Fluid Therapy, run by Ludhmila Abrahão Hajjar at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the stroke volume variation measured by both methods: transpulmonary thermodilution and electrical impedance tomography (EIT), during fluid responsiveness maneuvers and after fluid replacement in the immediate postoperative of coronary artery bypass grafting (CABG) patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Bypass Grafting, Fluid Therapy, Stroke Volume
- What is being tested?
- Passive Leg Raising (PLR) and PEEP increment (PEEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Aug 2018to 22 Jun 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective CABG surgery
- Age greater than 18 years old and less than 80 years old
- Written inform consent
Who cannot join
- Previous pulmonary disease or pulmonary hypertension
- Previous renal replacement therapy
- Left ventricular ejection fraction < 40%
- Body mass index > 40 kg/m2
- Atrial fibrillation
- Presence of cardiac pacemaker or another implantable electronic device
Show all 9Show fewer
- Bleeding associated to hemodynamic instability
- Cardiac arrest or suspicion of neurological alteration
- Hemodynamic instability (norepinephrine dose > 0.5 mcg/Kg/min)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute
São Paulo, São Paulo, 05403000
Ludhmila A Hajjar, MD, PhD, 11-26615232, ludhmila@usp.br
Rafael Ianotti, PT, 11-995989126, rafael.ianotti@gmail.com
About this study
Official title: Comparison of Dynamic Fluid Responsiveness Assessed by Electrical Impedance Tomography and Transpulmonary Thermodilution in Postoperative of Coronary Artery Bypass Grafting Patients
The purpose of this study is to evaluate the stroke volume variation measured by both methods: transpulmonary thermodilution and electrical impedance tomography (EIT), during fluid responsiveness maneuvers and after fluid replacement in the immediate postoperative of coronary artery bypass grafting (CABG) patients. Patients will be hemodinamically monitored with the VolumeView set in combination with EV1000 clinical platform and the display of valuable volumetric parameters (Edwards Lifesciences, California, USA). Simultaneoulsy, patients will be monitored with Enlight Electrical Impedance Tomography (Timpel, São Paulo, Brazil). Hemodynamic data will be assessed at baseline 1, one minute after the passive leg raising maneuver, after PEEP increment, and after 500 mL of Lactated Ringer's (bolus infusion). Blood gases sample will be assessed before and immediatly after the protocol.
Read the detailed description
In the ICU, immediately after CABG surgery, patients are submitted to mechanical ventilation (volume-controlled mode with tidal volume = 8mL/Kg of PBW, PEEP = 8cmH2O and FiO2 = 60%, respiratory rate to maintain PaCO2 = 35 - 45 mmHg); hemodynamically monitored with VolumeView set in combination with EV1000 clinical platform and the display of volumetric parameters (Edwards Lifesciences, California, USA). Electrical impedance tomography monitoring (Enlight, Timpel, São Paulo, Brazil) is performed with a pair of electrodes belt attached around the thorax at 4Th - 6Th intercostal space, and a flow sensor attached between the orotracheal tube and the Y connector from the ventilator.
Before initiate the protocol, patients are submitted to a bolus of usual care doses of sedation and muscular blockage (Fentanyl, Midazolam and Cisatracurium).
To assess fluid responsiveness patients will be submitted to two different maneuvers applied in a random way: Passive Leg Raising (PLR) ant PEEP increment (PEEP). And after these maneuvers patients will receive a bolus of 500 ml of Lactated Ringer's.
Measurements are performed one minute after each of these conditions:
- Baseline: before both fluid responsiveness maneuvers, before and after Lactated Ringer infusion, patient is positioned in 450 semi-recumbent position;
- PLR: Fluid responsiveness maneuver which patient is positioned from 450 semi-recumbent position to dorsal decubitus and the legs are raised at 450;
- PEEP increment: Fluid responsiveness maneuver which consisted in increased the PEEP level 5 cmH2O above the mean airway pressure, patient is positioned in 450 semi-recumbent position
- Infusion of 500 mL of Ringer's; 450 semi-recumbent position.
Transpulmonary Thermodilution assessment are performed by the injection of 3 cold salines in bolus - the injection volume varied from 10 - 20mL according to the patient's actual weight and EIT assessment are performed by 1 injection of 10 mL of hypertonic saline at 7.5 - 10% according to the patient's actual weight.
- Being tested
- Passive Leg Raising (PLR) and PEEP increment (PEEP)
- Keywords
- cardiac surgery, fluid responsiveness, transpulmonary thermodilution, electrical impedance tomography, passive leg raising, stroke volume variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Leg Raising (PLR) and PEEP increment (PEEP)Diagnostic test
PLR: Fluid responsiveness maneuver which patient is positioned from 45 grade of semi-recumbent position to dorsal decubitus and the legs are raised at 45 grades; PEEP increment: Fluid responsiveness maneuver which consisted in increased the PEEP level 5 cmH2O above the mean airway pressure, patient is positioned in 45 grade of semi-recumbent position
| Study group | Role | What they receive |
|---|---|---|
| PLR group | Experimental | Patients will be submitted to two different fluid responsiveness maneuvers in a cross over randomization:
In PLR arm, patients will be submitted to the PLR maneuver (patient is positioned from 45 grade of semi-recumbent position to dorsal decubitus and the legs are raised at 45 grade) firstly, then PEEP increment maneuver. At the end, all patients will receive a bolus of 500mL of Lactate Ringer's Receives: Diagnostic Test: Passive Leg Raising (PLR) and PEEP increment (PEEP) |
| PEEP group | Experimental | Patients will be submitted to two different fluid responsiveness maneuvers in a cross over randomization:
In PEEP arm, patients will be submitted to the PEEP maneuver (consisted in increase the PEEP level 5 cmH2O above the mean airway pressure, patient is positioned in 45 grade of semi-recumbent position) firstly, then PLR maneuver. At the end, all patients will receive a bolus of 500mL of Lactate Ringer's Receives: Diagnostic Test: Passive Leg Raising (PLR) and PEEP increment (PEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the variation of the stroke volume and impedance variation (mean difference in %)
Mean difference between stroke volume variation and impedance variation during different fluid responsiveness maneuvers, baseline condition and after volume infusion assessed by transpulmonary thermodilution and pulse contour method for stroke volume using VolumeView system, and electrical impedance parameters measured by Electrical impedance tomography for impedance variation
Measured: within 2 hours after patient admission in the ICU
Correlation between the variation of the stroke volume and impedance variation
Correlation test between the change (delta) of stroke volume and impedance variation during different fluid responsiveness maneuvers, baseline condition and after volume infusion assessed by transpulmonary thermodilution and pulse contour method for stroke volume using VolumeView system, and electrical impedance parameters measured by Electrical impedance tomography for impedance variation
Measured: within 2 hours after patient admission in the ICU
Secondary outcomes (4)
Agreement between stroke volume variation (delta) (mean difference in %, CI and limits of agreement)
To evaluate the accuracy of the passive leg elevation (PLR) maneuver as a predictor of fluid responsiveness in the immediate postoperative of CABG, we will compare the variation in stroke volume before-and-after PLR and before-and-after the infusion of 500mL of Ringer lactate
Measured: within 2 hours after patient admission in the ICU
Agreement between stroke volume variation (SVV) delta during PLR maneuver and with the infusion of volume
Comparison of Stroke volume variation (SVV) delta between passive leg raising and the infusion of 500mL of Ringer Lactate (mean difference in %, CI and limits of agreement)
Measured: within 2 hours after patient admission in the ICU
To evaluate the ability of increment of PEEP to predict fluid responsiveness
Comparisson between change in percentage of the stroke volume measure by VolumeView, during fluid responsiveness tested by PEEP increasing, Passive leg raising, and the Gold standard, fluid infusion of 500mL of Ringer Lactate
Measured: within 2 hours after patient admission in the ICU
Safety of assessment stroke volume by EIT during fluid responsiveness Test (delta of Sodium, in mEq/mL)
Mean difference in the plasmatic sodium measure before and after the protocol which include 6 injection of hypertonic saline
Measured: within 2 hours after patient admission in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start22 Aug 2018
- Primary completion22 Apr 2020 (estimated)
- Study completion22 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be submitted to two different fluid responsiveness maneuvers in a cross over randomization.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludhmila Abrahão Hajjar
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Sponsor-investigator, Ludhmila Abrahão Hajjar, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362033
- Sponsor's protocol ID
- 90728718.7.0000.0068
- Status last verified
- Jan 2020
- First submitted
- 31 Jan 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Braun F, Proenca M, Wendler A, Sola J, Lemay M, Thiran JP, Weiler N, Frerichs I, Becher T. Noninvasive measurement of stroke volume changes in critically ill patients by means of electrical impedance tomography. J Clin Monit Comput. 2020 Oct;34(5):903-911. doi: 10.1007/s10877-019-00402-z. Epub 2019 Oct 17.
PubMed 31624996
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dynamic Fluid Responsiveness Assessed by Electrical Impedance Tomography and Transpulmonary Thermodilution in Postoperative of Coronary Artery Bypass Grafting Patients
- ClinicalTrials.gov ID
- NCT04362033
- Acronym / sponsor ID
- 90728718.7.0000.0068
- Keywords
- cardiac surgery, fluid responsiveness, transpulmonary thermodilution, electrical impedance tomography, passive leg raising, stroke volume variation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ludhmila Abrahão HajjarUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 22 Apr 2020 (estimated)
- Study completion
- 22 Jun 2020 (estimated)
- First posted
- 24 Apr 2020 (actual)
- 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 purpose of this study is to evaluate the stroke volume variation measured by both methods: transpulmonary thermodilution and electrical impedance tomography (EIT), during fluid responsiveness maneuvers and after fluid replacement in the immediate postoperative of coronary artery bypass grafting (CABG) patients. Patients will be hemodinamically monitored with the VolumeView set in combination with EV1000 clinical platform and the display of valuable volumetric parameters (Edwards Lifesciences, California, USA). Simultaneoulsy, patients will be monitored with Enlight Electrical Impedance Tomography (Timpel, São Paulo, Brazil). Hemodynamic data will be assessed at baseline 1, one minute after the passive leg raising maneuver, after PEEP increment, and after 500 mL of Lactated Ringer's (bolus infusion). Blood gases sample will be assessed before and immediatly after the protocol.
Detailed description
In the ICU, immediately after CABG surgery, patients are submitted to mechanical ventilation (volume-controlled mode with tidal volume = 8mL/Kg of PBW, PEEP = 8cmH2O and FiO2 = 60%, respiratory rate to maintain PaCO2 = 35 - 45 mmHg); hemodynamically monitored with VolumeView set in combination with EV1000 clinical platform and the display of volumetric parameters (Edwards Lifesciences, California, USA). Electrical impedance tomography monitoring (Enlight, Timpel, São Paulo, Brazil) is performed with a pair of electrodes belt attached around the thorax at 4Th - 6Th intercostal space, and a flow sensor attached between the orotracheal tube and the Y connector from the ventilator.
Before initiate the protocol, patients are submitted to a bolus of usual care doses of sedation and muscular blockage (Fentanyl, Midazolam and Cisatracurium).
To assess fluid responsiveness patients will be submitted to two different maneuvers applied in a random way: Passive Leg Raising (PLR) ant PEEP increment (PEEP). And after these maneuvers patients will receive a bolus of 500 ml of Lactated Ringer's.
Measurements are performed one minute after each of these conditions:
- Baseline: before both fluid responsiveness maneuvers, before and after Lactated Ringer infusion, patient is positioned in 450 semi-recumbent position;
- PLR: Fluid responsiveness maneuver which patient is positioned from 450 semi-recumbent position to dorsal decubitus and the legs are raised at 450;
- PEEP increment: Fluid responsiveness maneuver which consisted in increased the PEEP level 5 cmH2O above the mean airway pressure, patient is positioned in 450 semi-recumbent position
- Infusion of 500 mL of Ringer's; 450 semi-recumbent position.
Transpulmonary Thermodilution assessment are performed by the injection of 3 cold salines in bolus - the injection volume varied from 10 - 20mL according to the patient's actual weight and EIT assessment are performed by 1 injection of 10 mL of hypertonic saline at 7.5 - 10% according to the patient's actual weight.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be submitted to two different fluid responsiveness maneuvers in a cross over randomization.
| Arm | Type | Receives |
|---|---|---|
| PLR group | Experimental | Diagnostic Test: Passive Leg Raising (PLR) and PEEP increment (PEEP)Patients will be submitted to two different fluid responsiveness maneuvers in a cross over randomization: In PLR arm, patients will be submitted to the PLR maneuver (patient is positioned from 45 grade of semi-recumbent position to dorsal decubitus and the legs are raised at 45 grade) firstly, then PEEP increment maneuver. At the end, all patients will receive a bolus of 500mL of Lactate Ringer's |
| PEEP group | Experimental | Diagnostic Test: Passive Leg Raising (PLR) and PEEP increment (PEEP)Patients will be submitted to two different fluid responsiveness maneuvers in a cross over randomization: In PEEP arm, patients will be submitted to the PEEP maneuver (consisted in increase the PEEP level 5 cmH2O above the mean airway pressure, patient is positioned in 45 grade of semi-recumbent position) firstly, then PLR maneuver. At the end, all patients will receive a bolus of 500mL of Lactate Ringer's |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective CABG surgery
- Age greater than 18 years old and less than 80 years old
- Written inform consent
Key exclusion criteria (9 listed)
- Previous pulmonary disease or pulmonary hypertension
- Previous renal replacement therapy
- Left ventricular ejection fraction < 40%
- Body mass index > 40 kg/m2
- Atrial fibrillation
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 |
|---|---|---|
| Passive Leg Raising (PLR) and PEEP increment (PEEP)PLR: Fluid responsiveness maneuver which patient is positioned from 45 grade of semi-recumbent position to dorsal decubitus and the legs are raised at 45 grades; PEEP increment: Fluid responsiveness maneuver which consisted in increased the PEEP level 5 cmH2O above the mean airway pressure, patient is positioned in 45 grade of semi-recumbent position | Diagnostic test | PEEP group, PLR group |
Primary outcome
Difference between the variation of the stroke volume and impedance variation (mean difference in %)
Time frame: within 2 hours after patient admission in the ICU
Mean difference between stroke volume variation and impedance variation during different fluid responsiveness maneuvers, baseline condition and after volume infusion assessed by transpulmonary thermodilution and pulse contour method for stroke volume using VolumeView system, and electrical impedance parameters measured by Electrical impedance tomography for impedance variation
Correlation between the variation of the stroke volume and impedance variation
Time frame: within 2 hours after patient admission in the ICU
Correlation test between the change (delta) of stroke volume and impedance variation during different fluid responsiveness maneuvers, baseline condition and after volume infusion assessed by transpulmonary thermodilution and pulse contour method for stroke volume using VolumeView system, and electrical impedance parameters measured by Electrical impedance tomography for impedance variation
4 secondary outcomes
Agreement between stroke volume variation (delta) (mean difference in %, CI and limits of agreement)
Time frame: within 2 hours after patient admission in the ICU
Agreement between stroke volume variation (SVV) delta during PLR maneuver and with the infusion of volume
Time frame: within 2 hours after patient admission in the ICU
To evaluate the ability of increment of PEEP to predict fluid responsiveness
Time frame: within 2 hours after patient admission in the ICU
Safety of assessment stroke volume by EIT during fluid responsiveness Test (delta of Sodium, in mEq/mL)
Time frame: within 2 hours after patient admission in the ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Results publication: PubMed 31624996Braun F, Proenca M, Wendler A, Sola J, Lemay M, Thiran JP, Weiler N, Frerichs I, Becher T. Noninvasive measurement of stroke volume changes in critically ill patients by means of electrical impedance tomography. J Clin Monit Comput. 2020 Oct;34(5):903-911. doi: 10.1007/s10877-019-00402-z. Epub 2019 Oct 17.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Leg Raising (PLR) and PEEP increment (PEEP) in people with Coronary Artery Bypass Grafting and Fluid Therapy, run by Ludhmila Abrahão Hajjar at 1 site in Brazil.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ludhmila A Hajjar, MD, PhD (11-26615000 ext. 5232, ludhmila@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the variation of the stroke volume and impedance variation (mean difference in %) (time frame: within 2 hours after patient admission in the ICU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362033, which also lists 1 linked publication.
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 24 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.