Back to resultsImpact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management (STOPFLUID)
Primary Purpose
Shock, Septic, Hemodynamic Instability
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echographic hemodynamic algorithm guiding fluid resuscitation
Sponsored by
About this trial
This is an interventional other trial for Shock, Septic focused on measuring Monitoring, Transthoracic Echocardiography, Blood Volume, Fluid management
Eligibility Criteria
All eligible patients will have a cardiac echocardiogram prior to inclusion for the sole purpose of eliminating special situations that are part of the non-inclusion criteria listed below. Inclusion Criteria Patient in an intensive care unit who develops septic shock on admission or during hospitalization, as defined by SEPSIS-3 criteria. Patient or trusted person / legal representative / family member / curator / guardian who has given free and informed consent and has signed the consent form or patient included in an emergency situation. Patient affiliated or beneficiary of a health insurance plan. Patient at least (≥) 18 years of age. Exclusion Criteria: Refusal of consent. Patient under court protection or guardianship. Moribund patient with a life expectancy of less than 48 hours. Non-echogenic patient. Cardiac tamponade. Infective endocarditis. Intracavitary thrombus. Dilated cardiomyopathy with LVEF (Left Ventricular Ejection Fraction<40%. Parturient or nursing patient.
Sites / Locations
- CHU de Nimes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional Strategy: STOPFLUID Algorithm
Standard Strategy
Arm Description
Fluid management is optimised using the specific echographic hemodynamic algorithm ('STOPFLUID') of this study described during the first 4 days of septic shock. Fluid bolus will not be administered in case of increased left ventricle filling pressures; fluid challenge will be performed based on dynamic indices and fluid depletion will be considered on the basis of Lung UltraSound (LUS) assessment.
Fluid management will be handled according to standard care, without using transthoracic echocardiography (TTE) during the first 4 days of septic shock management. Haemodynamic monitoring including pulmonary artery catheter, transpulmonary thermodilution, or any other device will be left at the physician's discretion. TTE will be allowed in the standard group only for excluding cardiac tamponade in case of clinical suspicion (one or more of the following signs: jugular distension, pulsus paradoxus)
Outcomes
Primary Outcome Measures
Volume of vascular filling during the first 4 days
This takes into account the cumulative volume of vascular filling administered to improve cardiac output during the 4 first days, measured in Liter (L)
Secondary Outcome Measures
.Analysis of the primary endpoint related to ARDS ([acute respiratory distress syndrome, according to Berlin criteria)
Analysis of the primary endpoint in relation with presence or absence of ARDS at inclusion
Analysis of the primary endpoint related to severe renal dysfunction
Analysis of the primary endpoint in relation with severe renal dysfunction defined as a KDIGO (Kidney Disease Improving Global Outcomes) score ≥3 vs <3.
Analysis of the primary endpoint in relation with patient severity
Analysis of the primary endpoint in relation withpatient severity according to SAPS 2 (Simplified Acute Physiology Score) score: <15, 15-30, >30
Mortality
Patient deceased: yes or no
Number of days alive without failure at Day 28
Number of days without failure
Time to normalization of lactatemia (<2 mmol/l)
Represents time from randomization to first lactatemia <2 mmol/l in hours
Fluid balance in L
The fluid balance will be deduced from the daily weight changes in kilograms, the density of water being equal to 1
Therapeutic adjustments including bolus vascular filling, changes in vasopressor flow, and administration of diuretics
Number of therapeutic adjustments
Length of stay in ICU (ready for discharge)
Length of stay in ICU from randomization to discharge in days
Length of stay in hospital
Number
Adverse effects
Number and type of adverse events
Full Information
NCT ID
NCT06043505
First Posted
June 30, 2023
Last Updated
September 12, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT06043505
Brief Title
Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management
Acronym
STOPFLUID
Official Title
Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management: a Multicentric, Randomized, Controlled, Open Label Pilot-study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 26, 2023 (Anticipated)
Primary Completion Date
September 26, 2024 (Anticipated)
Study Completion Date
October 26, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
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
Fluid management is one of the key issues in the initial management of septic shock (SS). Fluid overload and hypovolemia have been associated with increased mortality in several trials. Transthoracic echocardiography (TTE) and lung ultrasound are recommended for haemodynamic assessment in critically ill patients. However, the benefit of hemodynamic optimisation using echography has not been yet evaluated. The purpose of this multicenter, controlled, randomized trial is to assess the impact of an echocardiographic algorithm of hemodynamic optimization on fluid management in septic patients during the first 4 days of therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Septic, Hemodynamic Instability
Keywords
Monitoring, Transthoracic Echocardiography, Blood Volume, Fluid management
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional Strategy: STOPFLUID Algorithm
Arm Type
Experimental
Arm Description
Fluid management is optimised using the specific echographic hemodynamic algorithm ('STOPFLUID') of this study described during the first 4 days of septic shock. Fluid bolus will not be administered in case of increased left ventricle filling pressures; fluid challenge will be performed based on dynamic indices and fluid depletion will be considered on the basis of Lung UltraSound (LUS) assessment.
Arm Title
Standard Strategy
Arm Type
No Intervention
Arm Description
Fluid management will be handled according to standard care, without using transthoracic echocardiography (TTE) during the first 4 days of septic shock management. Haemodynamic monitoring including pulmonary artery catheter, transpulmonary thermodilution, or any other device will be left at the physician's discretion. TTE will be allowed in the standard group only for excluding cardiac tamponade in case of clinical suspicion (one or more of the following signs: jugular distension, pulsus paradoxus)
Intervention Type
Other
Intervention Name(s)
Echographic hemodynamic algorithm guiding fluid resuscitation
Intervention Description
Ultrasound Hemodynamic Algorithm (UHA):
st step: 1/ Assessment of left ventricular filling pressures by Mitral Doppler echocardiography (2) 2/ Pulmonary ultrasound on 4 anterior dials (3)
E/Ea >14 and/or E/A >2
YES => No filling test => Bilateral anterior B lines on lung ultrasound => YES => Consider administration of diuretics
NO => Step 2
nd step: Assessment of filling response by dynamic maneuvers VTI (Velocity Time Integral) increase >15% after passive leg raising (4) or Mini-fluid challenge (5,6) Or decision of a 250ml filling test
YES => consider 250ml bolus filling
NO => stop vascular filling
rd step if dynamic maneuvers in favor of a response to filling: 1/ Assessment of response to 250ml filling 2/ If no response to vascular filling: Pulmonary ultrasound on 4 anterior dials (3) Change from a pulmonary profile A to a pulmonary profile B
YES => depletion
NO => stop vascular filling
Primary Outcome Measure Information:
Title
Volume of vascular filling during the first 4 days
Description
This takes into account the cumulative volume of vascular filling administered to improve cardiac output during the 4 first days, measured in Liter (L)
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
.Analysis of the primary endpoint related to ARDS ([acute respiratory distress syndrome, according to Berlin criteria)
Description
Analysis of the primary endpoint in relation with presence or absence of ARDS at inclusion
Time Frame
Day 4
Title
Analysis of the primary endpoint related to severe renal dysfunction
Description
Analysis of the primary endpoint in relation with severe renal dysfunction defined as a KDIGO (Kidney Disease Improving Global Outcomes) score ≥3 vs <3.
Time Frame
Day 4
Title
Analysis of the primary endpoint in relation with patient severity
Description
Analysis of the primary endpoint in relation withpatient severity according to SAPS 2 (Simplified Acute Physiology Score) score: <15, 15-30, >30
Time Frame
Day 4
Title
Mortality
Description
Patient deceased: yes or no
Time Frame
Day 28
Title
Number of days alive without failure at Day 28
Description
Number of days without failure
Time Frame
Day 28
Title
Time to normalization of lactatemia (<2 mmol/l)
Description
Represents time from randomization to first lactatemia <2 mmol/l in hours
Time Frame
Day 4
Title
Fluid balance in L
Description
The fluid balance will be deduced from the daily weight changes in kilograms, the density of water being equal to 1
Time Frame
Day 4
Title
Therapeutic adjustments including bolus vascular filling, changes in vasopressor flow, and administration of diuretics
Description
Number of therapeutic adjustments
Time Frame
Day 4
Title
Length of stay in ICU (ready for discharge)
Description
Length of stay in ICU from randomization to discharge in days
Time Frame
Day 28
Title
Length of stay in hospital
Description
Number
Time Frame
Day 28
Title
Adverse effects
Description
Number and type of adverse events
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
All eligible patients will have a cardiac echocardiogram prior to inclusion for the sole purpose of eliminating special situations that are part of the non-inclusion criteria listed below.
Inclusion Criteria
Patient in an intensive care unit who develops septic shock on admission or during hospitalization, as defined by SEPSIS-3 criteria.
Patient or trusted person / legal representative / family member / curator / guardian who has given free and informed consent and has signed the consent form or patient included in an emergency situation.
Patient affiliated or beneficiary of a health insurance plan.
Patient at least (≥) 18 years of age.
Exclusion Criteria:
Refusal of consent.
Patient under court protection or guardianship.
Moribund patient with a life expectancy of less than 48 hours.
Non-echogenic patient.
Cardiac tamponade.
Infective endocarditis.
Intracavitary thrombus.
Dilated cardiomyopathy with LVEF (Left Ventricular Ejection Fraction<40%.
Parturient or nursing patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Roger, MD
Phone
04.66.68.30.50
Email
Claire.roger@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Roger
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Claire Pr ROGER, MD, PhD
First Name & Middle Initial & Last Name & Degree
Laurent Pr MULLER, MD, PhD
First Name & Middle Initial & Last Name & Degree
Dorian Dr DIDIER LECENE, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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22738085
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Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management
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