SepsisGENESISNCT04580888
Emergency Echocardiography in Sepsis
A study testing early transthoracic echocardiography and standards of care in people with Sepsis and Echocardiography, run by University Hospital, Limoges at 10 sites in France.
Trial summary
Acute circulatory failure that combines hypovolemia, vasoplegia and cardiac dysfunction plays a major role in the development of sepsis-related organ dysfunction. Pathophysiological mechanisms are multiple and complex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Echocardiography, Organ Dysfunction Syndrome Sepsis
- What is being tested?
- early transthoracic echocardiography and standards of care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 10 sitesFrance
- Study dates
- 23 Jul 2021to 15 Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the ED
- Age ≥ 18 years and affiliation to Social Security
- With sepsis (Sepsis-3 definition):
- Clinically suspected or documented acute infection
- AND a quick score Sequential Organ Failure Assessment (qSOFA) ≥ 2 points with:
- Systolic blood pressure ≤ 100 mmHg (1 point) requiring fluid loading
- AND encephalopathy (1 point) OR respiratory rate ≥ 22 cpm (1 point) AND a systolic blood pressure ≤ 100 mmHg after 500 mL of crystalloid vascular filling - Informed consent
Who cannot join
- Decision to limit care or moribund status
- Pregnancy or breast feeding
- Subject under juridical protection.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CH d'Albi
Albi, 81000
CH d'Eaubonne - Montmorency
Eaubonne, 95600
Grenoble university hospital
La Tronche, 38700
Limgoes university hospital
Limoges, 87042
Hospices civils de Lyon
Lyon, 69003
Nantes university hospital
Nantes, 44093
Nice university hospital
Nice, 06600
Poitiers university hospital
Poitiers, 86000
La réunion university hospital
Saint-Pierre, 97410
Toulouse university hospital
Toulouse, 31059
About this study
Official title: Impact of Early Haemodynamic Assessment by Echocardiography on Organ Dysfunction of Patients Admitted in the Emergency Department for Sepsis or Septic Shock
Acute circulatory failure that combines hypovolemia, vasoplegia and cardiac dysfunction plays a major role in the development of sepsis-related organ dysfunction. Pathophysiological mechanisms are multiple and complex. The objective of the GENESIS study is to determine the impact of early haemodynamic assessment using echocardiography in association with a therapeutic algorithm (intervention arm), when compared with standard of care based on the current Surviving Sepsis Campaign (SSC) recommendations (control arm), on the development of organ dysfunctions in patients admitted to the Emergency Department for sepsis or septic shock.
Read the detailed description
Sepsis is currently defined as life-threatening organ dysfunction secondary to a dysregulated host response to infection (Sepsis-3). Septic shock is a subgroup of patients who also have sustained arterial hypotension requiring vasopressors and tissue dysoxia. The mortality varies from 10 to 40% depending on the severity. The latest "bundles" of the SSC request to perform within the first hour of sepsis identification a fluid loading of 30 mL/kg of crystalloids in the presence of hypotension, and to initiate a vasopressor support in case of persistent hypotension to maintain a mean arterial pressure ≥ 65 mmHg. However, early fluid resuscitation is not necessarily associated with an improvement of sepsis prognosis and may even be deleterious when leading to excessive positive fluid balance. Accordingly, the SSC recommends investigating a personalized approach to define for each patient the appropriate volume of fluids to be administered according to the initial mechanism of sepsis-induced cardiovascular failure. Echocardiography is currently recommended as a first-line modality to identify the origin of acute circulatory failure, sepsis remaining the leading cause. It has been shown to alter ongoing treatment based on the sole SSC recommendations in the intensive care unit. In contrast, the impact of hemodynamic assessment using echocardiography at the early stage of sepsis in patients admitted to the Emergency Department (ED) is unknown.
In this randomized trial, patients will be either assessed hemodynamically using transthoracic echocardiography to guide early therapeutic management (intervention arm) or managed according to standards of care based on current SSC recommendations (control arm). Early echocardiography will be performed after 500 mL of fluid loading initiated upon identification of septic patients based on the qSOFA score (hemodynamic criterion required: systolic blood pressure ≤ 100 mmHg). This will allow identifying the hemodynamic profile at the origin of sepsis-induced circulatory failure and to monitor both the efficacy and tolerance of fluid resuscitation, or of any other therapeutic intervention (e.g., inotropic support) according to a predefined therapeutic algorithm. Patients allocated to the control arm will be managed conventionally according to current SSC recommendations, including a standardized fluid loading of 30 mL/kg.
Organ dysfunctions will be assessed in the two study arms by the SOFA score 24 hours after randomization and patient will be followed up until hospital discharge to determine outcome.
- Being tested
- early transthoracic echocardiography, standards of care
- Keywords
- Sepsis, Echocardiography, Haemodynamic, Emergency Medicine
- Medical subject headings
- Sepsis, Toxemia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early transthoracic echocardiographyProcedure or surgery
In the intervention arm, echocardiography will be performed immediately and potentially repeated to confirm the need for additional fluid resuscitation up to 30 mL/kg in the presence of persisting hypovolemia, or not (e.g., severe ventricular dysfunction). A therapeutic algorithm will allow standardized impact on ongoing management according to the hemodynamic profile identified by early echocardiography. After the completion of initial fluid resuscitation up to 30 mL/kg if required, a new echocardiographic assessment will be systematically performed by the same operator to stop or not fluid resuscitation, and to potentially initiate another treatment according to both the hemodynamic profile and clinical context.
standards of careProcedure or surgery
In the control arm, patients will be treated according to standards of care based on current SSC recommendations, including a fluid resuscitation of 30 mL/kg.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Assessment using an early transthoracic echocardiography (after 500 mL of fluids) to identify the hemodynamic profile responsible for the acute circulatory failure associated with sepsis / septic shock and to guide ongoing treatment (therapeutic algorithm) and monitor its efficacy and tolerance. Receives: Procedure: early transthoracic echocardiography |
| Control arm | Other | Conventional management according to current standards of care based on SSC recommendations, including a standardized fluid resuscitation of 30 mL/kg. Receives: Procedure: standards of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sequential Organ Failure Assessment (SOFA) score
Crude variation of the SOFA score between inclusion and 24h following randomization.
Measured: change from Hour 0 at Day 1
Secondary outcomes (20)
Interruption of fluid resuscitation
Number and proportion of patients in whom echocardiography performed in the ED (intervention arm) modified ongoing therapy based on SSC recommendations (standard of care) according to the hemodynamic profile. Interruption of fluid resuscitation before having administrated 30 mL/kg
Measured: Hour 3
Maintains of fluid resuscitation
Number and proportion of patients in whom echocardiography performed in the ED (intervention arm) modified ongoing therapy based on SSC recommendations (standard of care) according to the hemodynamic profile. Fluid resuscitation maintained beyond 30 mL/kg
Measured: Hour 3
Initiation of inotropes
Number and proportion of patients in whom echocardiography performed in the ED (intervention arm) modified ongoing therapy based on SSC recommendations (standard of care) according to the hemodynamic profile. Initiation of inotropes
Measured: Hour 3
Initiation of vasopressor support
Number and proportion of patients in whom echocardiography performed in the ED (intervention arm) modified ongoing therapy based on SSC recommendations (standard of care) according to the hemodynamic profile. Initiation of vasopressor support
Measured: Hour 3
Therapeutic modification
Number and proportion of patients in whom echocardiography performed in the ED (intervention arm) modified ongoing therapy based on SSC recommendations (standard of care) according to the hemodynamic profile. Therapeutic modification directly related to the echocardiographic examination
Measured: Hour 3
Persisting hypovolemia
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
Measured: Hour 0
Left ventricular failure
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
Measured: Hour 0
Vasoplegia with left ventricular hyperkinesia
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
Measured: Hour 0
Right ventricular failure
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
Measured: Hour 0
Stabilized hemodynamic status
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm). Stabilized hemodynamic status (none of above-mentioned abnormalities) due to adequate management of acute circulatory failure (avoid any deleterious therapeutic change).
Measured: Hour 0
Hydrostatic pulmonary edema
Number of Hydrostatic pulmonary edema (cardiogenic or volume overload) since potentially related to excessive fluid loading
Measured: through study completion, an average of 1 month
Supraventricular arrhythmias
Number of Supraventricular arrhythmias since potentially related to the initiation of positive inotropes
Measured: through study completion, an average of 1 month
ventricular arrhythmias
Number of ventricular arrhythmias since potentially related to the initiation of positive inotropes
Measured: through study completion, an average of 1 month
acute coronary syndrome,
Number of acute coronary syndrome since potentially related to the initiation of positive inotropes
Measured: through study completion, an average of 1 month
ischemic stroke
Number of ischemic stroke since potentially related to the initiation of positive inotropes
Measured: through study completion, an average of 1 month
hemorrhagic stroke
Number of hemorrhagic stroke since potentially related to the initiation of positive inotropes
Measured: through study completion, an average of 1 month
Lactate clearance
Lactate clearance (lactate 6h after randomization compared to lactate at baseline)
Measured: Hour 0 to Hour 6
septic shock
Number and proportion of patients who developed septic shock 24 h after inclusion
Measured: Hour 24
Patient course
Patient course after emergency department discharge: hospitalization in regular ward (medicine / surgery), stepdown unit or intensive care unit.
Measured: through study completion, an average of 1 month
Mortality
Mortality (all-cause and sepsis-related) at Day 7 and at hospital discharge
Measured: Day 7 and through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start23 Jul 2021
- Primary completion8 Apr 2025
- Study completion15 Apr 2025
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 SepsisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580888
- Sponsor's protocol ID
- 87RI19_0038 (GENESIS)
- Acronym
- GENESIS
- Status last verified
- Nov 2025
- First submitted
- 28 Sep 2020
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The dataset generated and/or analysed during the current study will be made available from the principal investigator on reasonable request. The conditions for the transfer of all or part of the database will be decided by the study sponsor and will be the subject of a written contract.
Publications
Lafon T, Le Gouge A, Brit S, Giraudeau B, Vignon P. Impact of early haemodynamic assessment by echocardiography on organ dysfunction and outcome of patients admitted to the emergency department with sepsis or septic shock: protocol of a multicentre randomised controlled trial (GENESIS). BMJ Open. 2025 May 6;15(5):e098304. doi: 10.1136/bmjopen-2024-098304.
PubMed 40335132
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Haemodynamic Assessment by Echocardiography on Organ Dysfunction of Patients Admitted in the Emergency Department for Sepsis or Septic Shock
- ClinicalTrials.gov ID
- NCT04580888
- Acronym / sponsor ID
- GENESIS / 87RI19_0038 (GENESIS)
- Keywords
- Sepsis, Echocardiography, Haemodynamic, Emergency Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 9 Oct 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.
Acute circulatory failure that combines hypovolemia, vasoplegia and cardiac dysfunction plays a major role in the development of sepsis-related organ dysfunction. Pathophysiological mechanisms are multiple and complex. The objective of the GENESIS study is to determine the impact of early haemodynamic assessment using echocardiography in association with a therapeutic algorithm (intervention arm), when compared with standard of care based on the current Surviving Sepsis Campaign (SSC) recommendations (control arm), on the development of organ dysfunctions in patients admitted to the Emergency Department for sepsis or septic shock.
Detailed description
Sepsis is currently defined as life-threatening organ dysfunction secondary to a dysregulated host response to infection (Sepsis-3). Septic shock is a subgroup of patients who also have sustained arterial hypotension requiring vasopressors and tissue dysoxia. The mortality varies from 10 to 40% depending on the severity. The latest "bundles" of the SSC request to perform within the first hour of sepsis identification a fluid loading of 30 mL/kg of crystalloids in the presence of hypotension, and to initiate a vasopressor support in case of persistent hypotension to maintain a mean arterial pressure ≥ 65 mmHg. However, early fluid resuscitation is not necessarily associated with an improvement of sepsis prognosis and may even be deleterious when leading to excessive positive fluid balance. Accordingly, the SSC recommends investigating a personalized approach to define for each patient the appropriate volume of fluids to be administered according to the initial mechanism of sepsis-induced cardiovascular failure. Echocardiography is currently recommended as a first-line modality to identify the origin of acute circulatory failure, sepsis remaining the leading cause. It has been shown to alter ongoing treatment based on the sole SSC recommendations in the intensive care unit. In contrast, the impact of hemodynamic assessment using echocardiography at the early stage of sepsis in patients admitted to the Emergency Department (ED) is unknown.
In this randomized trial, patients will be either assessed hemodynamically using transthoracic echocardiography to guide early therapeutic management (intervention arm) or managed according to standards of care based on current SSC recommendations (control arm). Early echocardiography will be performed after 500 mL of fluid loading initiated upon identification of septic patients based on the qSOFA score (hemodynamic criterion required: systolic blood pressure ≤ 100 mmHg). This will allow identifying the hemodynamic profile at the origin of sepsis-induced circulatory failure and to monitor both the efficacy and tolerance of fluid resuscitation, or of any other therapeutic intervention (e.g., inotropic support) according to a predefined therapeutic algorithm. Patients allocated to the control arm will be managed conventionally according to current SSC recommendations, including a standardized fluid loading of 30 mL/kg.
Organ dysfunctions will be assessed in the two study arms by the SOFA score 24 hours after randomization and patient will be followed up until hospital discharge to determine outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Procedure: early transthoracic echocardiographyAssessment using an early transthoracic echocardiography (after 500 mL of fluids) to identify the hemodynamic profile responsible for the acute circulatory failure associated with sepsis / septic shock and to guide ongoing treatment (therapeutic algorithm) and monitor its efficacy and tolerance. |
| Control arm | Other | Procedure: standards of careConventional management according to current standards of care based on SSC recommendations, including a standardized fluid resuscitation of 30 mL/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients admitted to the ED
- Age ≥ 18 years and affiliation to Social Security
- With sepsis (Sepsis-3 definition):
- Clinically suspected or documented acute infection
- Systolic blood pressure ≤ 100 mmHg (1 point) requiring fluid loading
Key exclusion criteria (3 listed)
- Decision to limit care or moribund status
- Pregnancy or breast feeding
- Subject under juridical protection.
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 |
|---|---|---|
| early transthoracic echocardiographyIn the intervention arm, echocardiography will be performed immediately and potentially repeated to confirm the need for additional fluid resuscitation up to 30 mL/kg in the presence of persisting hypovolemia, or not (e.g., severe ventricular dysfunction). A therapeutic algorithm will allow standardized impact on ongoing management according to the hemodynamic profile identified by early echocardiography. After the completion of initial fluid resuscitation up to 30 mL/kg if required, a new echocardiographic assessment will be systematically performed by the same operator to stop or not fluid resuscitation, and to potentially initiate another treatment according to both the hemodynamic profile and clinical context. | Procedure or surgery | Intervention arm |
| standards of careIn the control arm, patients will be treated according to standards of care based on current SSC recommendations, including a fluid resuscitation of 30 mL/kg. | Procedure or surgery | Control arm |
Primary outcome
Change in Sequential Organ Failure Assessment (SOFA) score
Time frame: change from Hour 0 at Day 1
Crude variation of the SOFA score between inclusion and 24h following randomization.
20 secondary outcomes
Interruption of fluid resuscitation
Time frame: Hour 3
Maintains of fluid resuscitation
Time frame: Hour 3
Initiation of inotropes
Time frame: Hour 3
Initiation of vasopressor support
Time frame: Hour 3
Therapeutic modification
Time frame: Hour 3
Persisting hypovolemia
Time frame: Hour 0
Left ventricular failure
Time frame: Hour 0
Vasoplegia with left ventricular hyperkinesia
Time frame: Hour 0
Right ventricular failure
Time frame: Hour 0
Stabilized hemodynamic status
Time frame: Hour 0
Hydrostatic pulmonary edema
Time frame: through study completion, an average of 1 month
Supraventricular arrhythmias
Time frame: through study completion, an average of 1 month
ventricular arrhythmias
Time frame: through study completion, an average of 1 month
acute coronary syndrome,
Time frame: through study completion, an average of 1 month
ischemic stroke
Time frame: through study completion, an average of 1 month
hemorrhagic stroke
Time frame: through study completion, an average of 1 month
Lactate clearance
Time frame: Hour 0 to Hour 6
septic shock
Time frame: Hour 24
Patient course
Time frame: through study completion, an average of 1 month
Mortality
Time frame: Day 7 and through study completion, an average of 1 month
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 21 Nov 2025.
- Derived from this study: PubMed 40335132Lafon T, Le Gouge A, Brit S, Giraudeau B, Vignon P. Impact of early haemodynamic assessment by echocardiography on organ dysfunction and outcome of patients admitted to the emergency department with sepsis or septic shock: protocol of a multicentre randomised controlled trial (GENESIS). BMJ Open. 2025 May 6;15(5):e098304. doi: 10.1136/bmjopen-2024-098304.
- Individual participant dataSharing planned: Undecided. The dataset generated and/or analysed during the current study will be made available from the principal investigator on reasonable request. The conditions for the transfer of all or part of the database will be decided by the study sponsor and will be the subject of a written contract.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early transthoracic echocardiography and standards of care in people with Sepsis and Echocardiography, run by University Hospital, Limoges at 10 sites 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 7 inclusion and 3 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
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?
Change in Sequential Organ Failure Assessment (SOFA) score (time frame: change from Hour 0 at Day 1). 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 NCT04580888, 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 21 Nov 2025.