Fluid ResponsivnessRAS-FRNCT06492044
Evaluation of the Association Between Right Atrial Reservoir Strain Variation and Fluid Responsiveness in Patients With Septic Shock
A study testing Transthoracic echocardiography (TTE) in people with Fluid Responsivness and Right Ventricle, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Evaluating preload dependence is crucial for managing fluid administration in septic shock patients. To avoid unnecessary fluid administration, it's recommended to use dynamic tests like the passive leg raising (PLR) maneuver or a fluid challenge (FC) to see if a patient's cardiac output will increase after fluid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Responsivness, Right Ventricle
- What is being tested?
- Transthoracic echocardiography (TTE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (>18 years old)
- Patient hospitalized in the Intensive Care Unit at Amiens University Hospital with septic shock for less than 48 hours, defined by the presence of all the following criteria: presence of sepsis, hypotension requiring vasopressors to maintain a mean arterial pressure ≥ 65 mmHg despite adequate prior fluid resuscitation, and blood lactate levels > 2 mmol/l (18 mg/dl).
- Patient requiring fluid resuscitation with crystalloids/colloids
- Patient on invasive mechanical ventilation in assisted-controlled mode.
- Blood pressure monitored via a radial or femoral arterial catheter connected to a MostCareUp (Vygon, France).
- Patient or family informed and non-opposition documented.
Who cannot join
- Poor echocardiographic image quality preventing RASr assessment
- Patient with a contraindication to the PLR maneuver: severe head trauma or intracranial hypertension
- Patient with a history of pericardiectomy
- Patient with a clinical examination consistent with abdominal compartment syndrome
- Patient with aortic pathology, mitral regurgitation greater than grade 2, tricuspid regurgitation greater than grade 2, mitral stenosis, or intracardiac shunt
- Patient with internal or external atrial/ventricular pacing
Show all 11Show fewer
- Pregnant woman
- Patient on extracorporeal membrane oxygenation and mechanical circulatory support
- Moribund patient
- Patient with supraventricular or ventricular arrhythmia during echocardiographic measurement series
- Patient on renal replacement therapy during echocardiographic examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens
Christophe Beyls, MD, 0322087866, Beyls.Christophe@chu-amiens.fr
About this study
Evaluating preload dependence is crucial for managing fluid administration in septic shock patients. To avoid unnecessary fluid administration, it's recommended to use dynamic tests like the passive leg raising (PLR) maneuver or a fluid challenge (FC) to see if a patient's cardiac output will increase after fluid resuscitation. Transthoracic echocardiography (TTE) is preferred for this because it can non-invasively, reliably, and reproducibly measure the increase in cardiac output. A patient is considered a "responder" if their stroke volume (SV) increases by more than 15% after an FC. Two-dimensional (2D) right atrial strain (RAS) is a promising tool for evaluating right atrial function. According to the Frank-Starling law, measuring changes in the RA reservoir strain phase (RASr) can identify acute changes in preload, like those induced by a PLR maneuver or an FC.
The aims of this study are to assess the ability of ∆RASr to identify responders after a fluid challenge (FC) and to evaluate the ability of ∆RASr variation induced by a PLR maneuver to distinguish responders from non-responders to volume expansion.
- Conditions
- Fluid Responsivness, Right Ventricle
- Being tested
- Transthoracic echocardiography (TTE)
- Keywords
- Right atrial strain, fluid responsivness, preload, right ventricle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiography (TTE)Other
In this pilot study, all included patients will undergo a TTE before (TTEt0) and after (TTEt1) the PLR maneuver, then before (TTEt2) and after the FC (TTEt3).
Passive leg raising is PLR. FC is fluid challenge. TTE, PLR and FC are routine care procedures in patient in septic shock. In this study the patient will undergo repeated image acquisition with TTE at different times as part of the study, resulting in a longer TTE procedure. The advantage of TTE is that it is a non-invasive, painless, non-irradiating procedure that can be easily performed at the patient's bedside and has no known side effects to date. TTE is a non-invasive procedure that poses no infectious or psychological risk to the patient. No additional follow-up or telephone contact will be necessary for the study. The study concludes once TTEt3 is completed.
| Study group | Role | What they receive |
|---|---|---|
| o Patient with septic shock for less than 48 hours | Experimental | Not described Receives: Other: Transthoracic echocardiography (TTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
∆RASrFC value in echocardiography after a fluid challenge
The ∆RASrFC will be defined as the difference between the RASr measured before the FC (RASrt2) and after the FC (RASrt3). To measure the RASr at different times, an acquisition of an apical four-chamber loop image focused on the right atrium will be performed at t0, t1, t2, and t3. The measurement of ∆RASrFC will be done offline, blinded to the results of ∆SVFC, by a cardiac echography expert using dedicated software.
T0 : refers to the time before the PLR maneuver
Measured: Baseline
∆RASrFC value in echocardiography after a fluid challenge
The ∆RASrFC will be defined as the difference between the RASr measured before the FC (RASrt2) and after the FC (RASrt3). To measure the RASr at different times, an acquisition of an apical four-chamber loop image focused on the right atrium will be performed at t0, t1, t2, and t3. The measurement of ∆RASrFC will be done offline, blinded to the results of ∆SVFC, by a cardiac echography expert using dedicated software.
T1 refers to the time during the PLR maneuver at the peak of the maximal velocity of the aortic VTI.
Measured: 10 minutes
∆RASrFC value in echocardiography after a fluid challenge
The ∆RASrFC will be defined as the difference between the RASr measured before the FC (RASrt2) and after the FC (RASrt3). To measure the RASr at different times, an acquisition of an apical four-chamber loop image focused on the right atrium will be performed at t0, t1, t2, and t3. The measurement of ∆RASrFC will be done offline, blinded to the results of ∆SVFC, by a cardiac echography expert using dedicated software.
T2 refers to the time before the fluid challenge (FC)
Measured: 30 minutes
∆RASrFC value in echocardiography after a fluid challenge
The ∆RASrFC will be defined as the difference between the RASr measured before the FC (RASrt2) and after the FC (RASrt3). To measure the RASr at different times, an acquisition of an apical four-chamber loop image focused on the right atrium will be performed at t0, t1, t2, and t3. The measurement of ∆RASrFC will be done offline, blinded to the results of ∆SVFC, by a cardiac echography expert using dedicated software.
T3 period refers to the time after the end of the FC (15 minutes).
Measured: 45 minuntes
Secondary outcomes (7)
∆RASr value after the PLR maneuver
- ∆RASrPLR will be defined as the difference between the RASr measured before the PLR maneuver (RASrt0) and the RASr measured during the PLR maneuver at the peak of the maximal velocity of the aortic VTI (RASrt1).
T1 period refers to the time during the PLR maneuver at the peak of the maximal velocity of the aortic VTI.
Measured: 10 minutes
Comparison between SV measured by TTE and SV measured
Comparison between SV measured by TTE and SV measured by MostCareUp during the PLR maneuver and the FC.
SV measured by MostCareUp is based on the PRAM (pressure recording analytical method). This is an uncalibrated monitoring method based on pulse wave analysis.
the T1 period refers to the time during the PLR maneuver at the peak of the maximal velocity of the aortic VTI.
Measured: 10 minutes
Association between RASr and CVP
Evaluation of the association between RASr, ∆RASrFC, CVP and ∆CVP. ∆CVPFC will be defined as the difference between the CVP measured at time t2 and at time t3. CVP is measured at end-expiration using a jugular venous catheter and will be the average of three consecutive measurements.
T3 period refers to the time after the end of the FC
Measured: 45 minutes
Evaluation of right ventricular-arterial coupling in the context of septic shock
Right ventricular-arterial coupling is measured by TTE at times t0, t1, t2 and t3 using a four-chamber view and the TAPSE/PASP parameter.
Measured: Baseline
Evaluation of right ventricular-arterial coupling in the context of septic shock
Right ventricular-arterial coupling is measured by TTE at times t0, t1, t2 and t3 using a four-chamber view and the TAPSE/PASP parameter.
Measured: 10 minutes
Evaluation of right ventricular-arterial coupling in the context of septic shock
Right ventricular-arterial coupling is measured by TTE at times t0, t1, t2 and t3 using a four-chamber view and the TAPSE/PASP parameter.
Measured: 30 minutes
Evaluation of right ventricular-arterial coupling in the context of septic shock
Right ventricular-arterial coupling is measured by TTE at times t0, t1, t2 and t3 using a four-chamber view and the TAPSE/PASP parameter.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start10 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivnessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492044
- Sponsor's protocol ID
- PI2022_843_0104
- Acronym
- RAS-FR
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 10 Jul 2024
- 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between Right Atrial Reservoir Strain Variation and Fluid Responsiveness in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT06492044
- Acronym / sponsor ID
- RAS-FR / PI2022_843_0104
- Conditions
- Fluid Responsivness, Right Ventricle
- Keywords
- Right atrial strain, fluid responsivness, preload, right ventricle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jul 2024 (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.
Evaluating preload dependence is crucial for managing fluid administration in septic shock patients. To avoid unnecessary fluid administration, it's recommended to use dynamic tests like the passive leg raising (PLR) maneuver or a fluid challenge (FC) to see if a patient's cardiac output will increase after fluid resuscitation. Transthoracic echocardiography (TTE) is preferred for this because it can non-invasively, reliably, and reproducibly measure the increase in cardiac output. A patient is considered a "responder" if their stroke volume (SV) increases by more than 15% after an FC. Two-dimensional (2D) right atrial strain (RAS) is a promising tool for evaluating right atrial function. According to the Frank-Starling law, measuring changes in the RA reservoir strain phase (RASr) can identify acute changes in preload, like those induced by a PLR maneuver or an FC.
The aims of this study are to assess the ability of ∆RASr to identify responders after a fluid challenge (FC) and to evaluate the ability of ∆RASr variation induced by a PLR maneuver to distinguish responders from non-responders to volume expansion.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| o Patient with septic shock for less than 48 hours | Experimental | Other: Transthoracic echocardiography (TTE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient (>18 years old)
- Patient hospitalized in the Intensive Care Unit at Amiens University Hospital with septic shock for less than 48 hours, defined by the presence of all the following criteria: presence of sepsis, hypotension requiring vasopressors to maintain a mean arterial pressure ≥ 65 mmHg despite adequate prior fluid resuscitation, and blood lactate levels > 2 mmol/l (18 mg/dl).
- Patient requiring fluid resuscitation with crystalloids/colloids
- Patient on invasive mechanical ventilation in assisted-controlled mode.
- Blood pressure monitored via a radial or femoral arterial catheter connected to a MostCareUp (Vygon, France).
Key exclusion criteria (11 listed)
- Poor echocardiographic image quality preventing RASr assessment
- Patient with a contraindication to the PLR maneuver: severe head trauma or intracranial hypertension
- Patient with a history of pericardiectomy
- Patient with a clinical examination consistent with abdominal compartment syndrome
- Patient with aortic pathology, mitral regurgitation greater than grade 2, tricuspid regurgitation greater than grade 2, mitral stenosis, or intracardiac shunt
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 |
|---|---|---|
| Transthoracic echocardiography (TTE)In this pilot study, all included patients will undergo a TTE before (TTEt0) and after (TTEt1) the PLR maneuver, then before (TTEt2) and after the FC (TTEt3). Passive leg raising is PLR. FC is fluid challenge. TTE, PLR and FC are routine care procedures in patient in septic shock. In this study the patient will undergo repeated image acquisition with TTE at different times as part of the study, resulting in a longer TTE procedure. The advantage of TTE is that it is a non-invasive, painless, non-irradiating procedure that can be easily performed at the patient's bedside and has no known side effects to date. TTE is a non-invasive procedure that poses no infectious or psychological risk to the patient. No additional follow-up or telephone contact will be necessary for the study. The study concludes once TTEt3 is completed. | Other | o Patient with septic shock for less than 48 hours |
Primary outcome
∆RASrFC value in echocardiography after a fluid challenge
Time frame: Baseline
The ∆RASrFC will be defined as the difference between the RASr measured before the FC (RASrt2) and after the FC (RASrt3). To measure the RASr at different times, an acquisition of an apical four-chamber loop image focused on the right atrium will be performed at t0, t1, t2, and t3. The measurement of ∆RASrFC will be done offline, blinded to the results of ∆SVFC, by a cardiac echography expert using dedicated software. T0 : refers to the time before the PLR maneuver
∆RASrFC value in echocardiography after a fluid challenge
Time frame: 10 minutes
The ∆RASrFC will be defined as the difference between the RASr measured before the FC (RASrt2) and after the FC (RASrt3). To measure the RASr at different times, an acquisition of an apical four-chamber loop image focused on the right atrium will be performed at t0, t1, t2, and t3. The measurement of ∆RASrFC will be done offline, blinded to the results of ∆SVFC, by a cardiac echography expert using dedicated software. T1 refers to the time during the PLR maneuver at the peak of the maximal velocity of the aortic VTI.
∆RASrFC value in echocardiography after a fluid challenge
Time frame: 30 minutes
The ∆RASrFC will be defined as the difference between the RASr measured before the FC (RASrt2) and after the FC (RASrt3). To measure the RASr at different times, an acquisition of an apical four-chamber loop image focused on the right atrium will be performed at t0, t1, t2, and t3. The measurement of ∆RASrFC will be done offline, blinded to the results of ∆SVFC, by a cardiac echography expert using dedicated software. T2 refers to the time before the fluid challenge (FC)
∆RASrFC value in echocardiography after a fluid challenge
Time frame: 45 minuntes
The ∆RASrFC will be defined as the difference between the RASr measured before the FC (RASrt2) and after the FC (RASrt3). To measure the RASr at different times, an acquisition of an apical four-chamber loop image focused on the right atrium will be performed at t0, t1, t2, and t3. The measurement of ∆RASrFC will be done offline, blinded to the results of ∆SVFC, by a cardiac echography expert using dedicated software. T3 period refers to the time after the end of the FC (15 minutes).
7 secondary outcomes
∆RASr value after the PLR maneuver
Time frame: 10 minutes
Comparison between SV measured by TTE and SV measured
Time frame: 10 minutes
Association between RASr and CVP
Time frame: 45 minutes
Evaluation of right ventricular-arterial coupling in the context of septic shock
Time frame: Baseline
Evaluation of right ventricular-arterial coupling in the context of septic shock
Time frame: 10 minutes
Evaluation of right ventricular-arterial coupling in the context of septic shock
Time frame: 30 minutes
Evaluation of right ventricular-arterial coupling in the context of septic shock
Time frame: 45 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic echocardiography (TTE) in people with Fluid Responsivness and Right Ventricle, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 10 Jul 2024. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Beyls, MD (03 22 08 80 51, beyls.christophe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
∆RASrFC value in echocardiography after a fluid challenge (time frame: Baseline). The study lists 4 primary outcomes in all. 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 10 Jul 2024.