Emergency Echocardiography in Sepsis

NCT04580888 | Completed

• 1 other identifier: 87RI19_0038 (GENESIS)
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 10

Brief 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. 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.

Conditions

Sepsis; Echocardiography; Organ Dysfunction Syndrome Sepsis; Emergencies

Keywords

Sepsis; Echocardiography; Haemodynamic; Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• Change in Sequential Organ Failure Assessment (SOFA) score

  Crude variation of the SOFA score between inclusion and 24h following randomization.

  change from Hour 0 at Day 1

Secondary Outcomes (20)

• Interruption of fluid resuscitation

  Hour 3

• Maintains of fluid resuscitation

  Hour 3

• Initiation of inotropes

  Hour 3

• Initiation of vasopressor support

  Hour 3

• Therapeutic modification

  Hour 3

Study Arms (2)

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.

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.

Procedure: standards of care

Interventions

early transthoracic echocardiography PROCEDURE

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.

Intervention arm

standards of care PROCEDURE

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.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Decision to limit care or moribund status
• Pregnancy or breast feeding
• Subject under juridical protection.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (10)

CH d'Albi

Albi, 81000, France

Location

CH d'Eaubonne - Montmorency

Eaubonne, 95600, France

Location

Grenoble university hospital

La Tronche, 38700, France

Location

Limgoes university hospital

Limoges, 87042, France

Location

Hospices civils de Lyon

Lyon, 69003, France

Location

Nantes university hospital

Nantes, 44093, France

Location

Nice university hospital

Nice, 06600, France

Location

Poitiers university hospital

Poitiers, 86000, France

Location

La réunion university hospital

Saint-Pierre, 97410, France

Location

Toulouse university hospital

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 40335132 DERIVED

MeSH Terms

Conditions

Sepsis; Toxemia; Emergencies

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 9, 2020
• Study Start: July 23, 2021
• Primary Completion: April 8, 2025
• Study Completion: April 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

FR (10)