search
Back to results

Emergency Echocardiography in Sepsis (GENESIS)

Primary Purpose

Sepsis, Echocardiography, Organ Dysfunction Syndrome Sepsis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
early transthoracic echocardiography
standards of care
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Echocardiography, Haemodynamic, Emergency Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • CH d'AlbiRecruiting
  • Bordeaux university hospitalRecruiting
  • CH d'Eaubonne - Montmorency
  • Grenoble university hospitalRecruiting
  • Hopital de VersaillesRecruiting
  • Limgoes university hospitalRecruiting
  • Hospices civils de LyonRecruiting
  • Nantes university hospitalRecruiting
  • Nice university hospitalRecruiting
  • Hopital lariboisièreRecruiting
  • Poitiers university hospitalRecruiting
  • La réunion university hospitalRecruiting
  • Toulouse university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention arm

Control arm

Arm Description

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.

Conventional management according to current standards of care based on SSC recommendations, including a standardized fluid resuscitation of 30 mL/kg.

Outcomes

Primary Outcome Measures

Change in Sequential Organ Failure Assessment (SOFA) score
Crude variation of the SOFA score between inclusion and 24h following randomization.

Secondary Outcome Measures

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
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
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
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
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
Persisting hypovolemia
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
Left ventricular failure
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
Vasoplegia with left ventricular hyperkinesia
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
Right ventricular failure
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
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).
Hydrostatic pulmonary edema
Number of Hydrostatic pulmonary edema (cardiogenic or volume overload) since potentially related to excessive fluid loading
Supraventricular arrhythmias
Number of Supraventricular arrhythmias since potentially related to the initiation of positive inotropes
ventricular arrhythmias
Number of ventricular arrhythmias since potentially related to the initiation of positive inotropes
acute coronary syndrome,
Number of acute coronary syndrome since potentially related to the initiation of positive inotropes
ischemic stroke
Number of ischemic stroke since potentially related to the initiation of positive inotropes
hemorrhagic stroke
Number of hemorrhagic stroke since potentially related to the initiation of positive inotropes
Lactate clearance
Lactate clearance (lactate 6h after randomization compared to lactate at baseline)
septic shock
Number and proportion of patients who developed septic shock 24 h after inclusion
Patient course
Patient course after emergency department discharge: hospitalization in regular ward (medicine / surgery), stepdown unit or intensive care unit.
Mortality
Mortality (all-cause and sepsis-related) at Day 7 and at hospital discharge

Full Information

First Posted
September 28, 2020
Last Updated
May 24, 2023
Sponsor
University Hospital, Limoges
search

1. Study Identification

Unique Protocol Identification Number
NCT04580888
Brief Title
Emergency Echocardiography in Sepsis
Acronym
GENESIS
Official Title
Impact of Early Haemodynamic Assessment by Echocardiography on Organ Dysfunction of Patients Admitted in the Emergency Department for Sepsis or Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2021 (Actual)
Primary Completion Date
August 23, 2025 (Anticipated)
Study Completion Date
August 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Echocardiography, Organ Dysfunction Syndrome Sepsis, Emergencies
Keywords
Sepsis, Echocardiography, Haemodynamic, Emergency Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Other
Arm Description
Conventional management according to current standards of care based on SSC recommendations, including a standardized fluid resuscitation of 30 mL/kg.
Intervention Type
Procedure
Intervention Name(s)
early transthoracic echocardiography
Intervention Description
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 Type
Procedure
Intervention Name(s)
standards of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Sequential Organ Failure Assessment (SOFA) score
Description
Crude variation of the SOFA score between inclusion and 24h following randomization.
Time Frame
change from Hour 0 at Day 1
Secondary Outcome Measure Information:
Title
Interruption of fluid resuscitation
Description
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
Time Frame
Hour 3
Title
Maintains of fluid resuscitation
Description
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
Time Frame
Hour 3
Title
Initiation of inotropes
Description
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
Time Frame
Hour 3
Title
Initiation of vasopressor support
Description
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
Time Frame
Hour 3
Title
Therapeutic modification
Description
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
Time Frame
Hour 3
Title
Persisting hypovolemia
Description
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
Time Frame
Hour 0
Title
Left ventricular failure
Description
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
Time Frame
Hour 0
Title
Vasoplegia with left ventricular hyperkinesia
Description
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
Time Frame
Hour 0
Title
Right ventricular failure
Description
Number and proportion of patients presenting at the time of early hemodynamic assessment using echocardiography (intervention arm)
Time Frame
Hour 0
Title
Stabilized hemodynamic status
Description
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).
Time Frame
Hour 0
Title
Hydrostatic pulmonary edema
Description
Number of Hydrostatic pulmonary edema (cardiogenic or volume overload) since potentially related to excessive fluid loading
Time Frame
through study completion, an average of 1 month
Title
Supraventricular arrhythmias
Description
Number of Supraventricular arrhythmias since potentially related to the initiation of positive inotropes
Time Frame
through study completion, an average of 1 month
Title
ventricular arrhythmias
Description
Number of ventricular arrhythmias since potentially related to the initiation of positive inotropes
Time Frame
through study completion, an average of 1 month
Title
acute coronary syndrome,
Description
Number of acute coronary syndrome since potentially related to the initiation of positive inotropes
Time Frame
through study completion, an average of 1 month
Title
ischemic stroke
Description
Number of ischemic stroke since potentially related to the initiation of positive inotropes
Time Frame
through study completion, an average of 1 month
Title
hemorrhagic stroke
Description
Number of hemorrhagic stroke since potentially related to the initiation of positive inotropes
Time Frame
through study completion, an average of 1 month
Title
Lactate clearance
Description
Lactate clearance (lactate 6h after randomization compared to lactate at baseline)
Time Frame
Hour 0 to Hour 6
Title
septic shock
Description
Number and proportion of patients who developed septic shock 24 h after inclusion
Time Frame
Hour 24
Title
Patient course
Description
Patient course after emergency department discharge: hospitalization in regular ward (medicine / surgery), stepdown unit or intensive care unit.
Time Frame
through study completion, an average of 1 month
Title
Mortality
Description
Mortality (all-cause and sepsis-related) at Day 7 and at hospital discharge
Time Frame
Day 7 and through study completion, an average of 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Decision to limit care or moribund status Pregnancy or breast feeding Subject under juridical protection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LAFON Thomas, MD
Phone
555056254
Ext
+33
Email
thomas.lafon@chu-limoges.fr
First Name & Middle Initial & Last Name or Official Title & Degree
BOURZEIX Paul, MD
Phone
555058841
Ext
+33
Email
paul.bourzeix@chu-limoges.fr
Facility Information:
Facility Name
CH d'Albi
City
Albi
ZIP/Postal Code
81000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur BAISSE, MD
Email
arthurbaisse@hotmail.com
First Name & Middle Initial & Last Name & Degree
Arthur BAISSE, MD
Facility Name
Bordeaux university hospital
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel GALINSKI, MD
Phone
556794826
Ext
+33
Email
michel.galinski@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Michel GALINSKI, MD
Facility Name
CH d'Eaubonne - Montmorency
City
Eaubonne
ZIP/Postal Code
95600
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime GAUTIER, MD
Phone
134066755
Ext
+33
Email
maxime.gautier@ch-simoneveil.fr
First Name & Middle Initial & Last Name & Degree
Maxime GAUTIER, MD
Facility Name
Grenoble university hospital
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien VIGLINO, MD
Phone
476765934
Ext
+33
Email
dviglino@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Damien VIGLINO, MD
Facility Name
Hopital de Versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludovic DALLE, MD
Email
ldalle@ch-versailles.fr
First Name & Middle Initial & Last Name & Degree
Ludovic DALLE, MD
Facility Name
Limgoes university hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LAFON Thomas, MD
Phone
555056254
Ext
+33
Email
thomas.lafon@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
BOURZEIX Paul, MD
Phone
555058841
Ext
+33
Email
paul.bourzeix@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
LAFON Thomas, MD
First Name & Middle Initial & Last Name & Degree
BAISSE Arthur, MD
Facility Name
Hospices civils de Lyon
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile DELAHAYE, MD
Phone
472119572
Ext
+33
Email
cecile.delahaye@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Cécile DELAHAYE, MD
Facility Name
Nantes university hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe LE CONTE, MD
Phone
240083934
Ext
+33
Email
philippe.leconte@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Philippe LE CONTE, MD
Facility Name
Nice university hospital
City
Nice
ZIP/Postal Code
06600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie CONTENTI, MD
Phone
492033242
Ext
+33
Email
contenti.j@chu-nice.fr
Facility Name
Hopital lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony CHAUVIN, MD
Email
anthony.chauvin@aphp.fr
First Name & Middle Initial & Last Name & Degree
Anthony CHAUVIN, MD
Facility Name
Poitiers university hospital
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas MARJANOVIC, MD
Phone
549444444
Ext
+33
Email
nicolas.marjanovic@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Nicolas MARJANOVIC, MD
Facility Name
La réunion university hospital
City
Saint-Pierre
ZIP/Postal Code
97410
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrien VAGUE, MD
Phone
693130226
Ext
+33
Email
adrien.vague@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Adrien VAGUE, MD
Facility Name
Toulouse university hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric BALEN, MD
Phone
561772379
Ext
+33
Email
balen.f@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Frédéric BALEN, MD

12. IPD Sharing Statement

Learn more about this trial

Emergency Echocardiography in Sepsis

We'll reach out to this number within 24 hrs