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Evolution of Muscle Function, Breathlessness and Quality of Life Following Intra or Extra-Abdominal Sepsis in ICU Patients (EMBLemAticS)

Primary Purpose

Sepsis, Septic Shock

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound measurement of the diaphragm and intercostals
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sepsis

Eligibility Criteria

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

Inclusion Criteria: Patient over 18 years of age, Patient admitted to a critical care unit at Paris Saint-Joseph Hospital, Sepsis or septic shock (defined by the international consensus conference "sepsis-3"), Sepsis/septic shock less than 72 hours old, Patient affiliated to a health insurance scheme, French-speaking patient, Patient or relative who has given free, informed and express consent. Exclusion Criteria: History of documented chronic muscular disease, whatever the cause (neuromuscular damage, abdominal or diaphragmatic hernia, muscular damage of inflammatory origin, myopathies, etc.), Moribund patients, Patient already included in a type 1 interventional research protocol (RIPH1), Patient under guardianship, Patient deprived of liberty, Patient under court protection, Pregnant patient.

Sites / Locations

  • Hôpital Paris Saint-JosephRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasound measurement of the diaphragm and intercostals

Arm Description

The specific research procedures correspond to the addition of : Two additional ultrasound examinations, i.e. at discharge from intensive care and 3 months after hospital discharge: non-invasive examination (duration 20 minutes). Ultrasound is a risk-free, painless procedure involving the placement of an ultrasound probe on the body part under investigation, without the need for a radius or puncture. Questionnaires to assess quality of life (SF-36) and functional impact (LCADL) of dyspnea, carried out at discharge from hospital and at 3 months (duration 15 minutes).

Outcomes

Primary Outcome Measures

Diaphragm thickening function
This outcome corresponds to the difference in mean ultrasound diaphragm thickening fraction between ICU discharge and 3 months after hospital discharge.

Secondary Outcome Measures

Function of thickening the diaphragm during inspiratory efforts
This outcome corresponds to the difference in mean between the two groups in the fraction of diaphragm thickening, on ultrasound, within the first 72 hours of admission and on discharge from the intensive care unit.
Evolution of diaphragm mobility during inspiratory efforts
This outcome corresponds to the difference in diaphragmatic excursion means within the first 72 hours of admission, at discharge from intensive care and 3 months after hospital discharge.
Evolution of intercostal, transversus abdominis and oblique abdominal muscle function
This outcome corresponds to the comparison of thickness of intercostal, transverse and oblique abdominal muscles within the first 72 hours of admission, on discharge from intensive care and 3 months after hospital discharge.
Evolution of the cross-sectional area of the rectus femoris on ultrasound
This outcome corresponds to the comparison of the cross-sectional area of the rectus femoris within the first 72 hours of admission, on discharge from the intensive care unit and 3 months after hospital discharge.
Evolution of the structure of the various muscle groups assessed by ultrasound
This outcome corresponds to the comparison of gray levels on image captures of different muscle groups using Image J software®.
Global measurement of dyspnea
This outcome corresponds to theVAS-Dyspnea comparison (numerical scale from 0 to 10) within the first 72 hours of admission to intensive care, at discharge from intensive care, at discharge from hospital and 3 months after discharge from hospital.
Functional impact of dyspnea
This outcome corresponds to london chest activity of daily living scale at hospital discharge (estimate of previous condition) and 3 months after discharge. london chest activity of daily living
Short Form-36 Questionnaire of Quality of life
This outcome corresponds to the Short Form-36 comparison at hospital discharge (estimate of previous condition) and 3 months after discharge.
Relationship between diaphragm function and dyspnea, and quality of life
This outcome corresponds to the correlation between diaphragm thickening fraction and LCADL scale, SF-36 quality-of-life questionnaire physical score.

Full Information

First Posted
August 8, 2023
Last Updated
August 24, 2023
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT06010186
Brief Title
Evolution of Muscle Function, Breathlessness and Quality of Life Following Intra or Extra-Abdominal Sepsis in ICU Patients
Acronym
EMBLemAticS
Official Title
Evolution of Muscle Function, Breathlessness and Quality of Life Following Intra or Extra-Abdominal Sepsis in ICU Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
July 27, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

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
Sepsis is organ dysfunction secondary to an inappropriate host response to infection. In the most severe cases, circulatory failure necessitating the introduction of vasopressor therapy is called septic shock. Sepsis and septic shock are life-threatening systemic organ dysfunctions requiring hospitalization in a critical care unit. According to several studies, sepsis accounts for around 30% of patients in these units. In this patient population, mortality in the critical care unit or in hospital is 25.8% and 35.3% respectively. Among the organ dysfunctions associated with sepsis, striated skeletal muscle damage is frequent and possibly severe. The literature refers to this as sepsis-induced myopathy, and describes three main mechanisms: mitochondrial dysfunction, exacerbated proteolysis and altered muscle membrane excitability. Of all the striated skeletal muscles that can be affected, the diaphragm and the muscles of the thoracic and abdominal wall play a major role in breathing. The diaphragm remains the main muscle involved in breathing. Its physiology is twofold. Firstly, through its contraction, the diaphragm is responsible for the lateral movement of the lower ribs, thus increasing the transverse diameter of the thorax. This first action is commonly referred to as "insertional". At the same time, lowering the phrenic center of the diaphragm increases abdominal pressure. Its distinctive upwardly convex domed appearance means that it is intimately in contact with both the chest wall and the abdominal cavity. This particular area of contact is called the apposition zone. It is on this zone, under the action of the abdominal compartment, that positive pressure also generates an outward thrust from the medial face of the lower ribs, a second action commonly referred to as "appositional". A number of studies, including that carried out by our team (US_DIAMONDS, NCT 02474797), have identified a high prevalence of diaphragmatic damage in patients with sepsis or septic shock. This can be as high as 60%. This diaphragmatic dysfunction would then be associated with a higher mortality rate in hospital and at D90 of discharge. The clinical evolution of post-resuscitation patients remains a little-studied subject. However, patients may present muscle dysfunctions in the longer term after a stay in intensive care. In our study, we demonstrated that less than half of patients recovered from diaphragmatic dysfunction on discharge from the critical care unit. In addition, Borges RC et al. found a significant decrease in the cross-sectional area of the rectus femoris at discharge, compared with the same measurement taken at D+2 of admission to the critical care unit. Finally, the impact of muscle dysfunction on dyspnoea during sepsis and after its resolution is uncertain. Similarly, the impact of muscle dysfunction and dyspnoea on quality of life is unknown. Sepsis is associated with muscle dysfunction of multiple mechanisms. The aim of this study is to assess the immediate and longer-term impact of muscle dysfunction on muscle, dyspnea and quality of life in patients with abdominal sepsis ("Abdominal sepsis" group) and patients with extra-abdominal sepsis ("Extra-abdominal" group). Depending on the location of sepsis, this study will enable us to assess and potentially confirm the preferential effect of abdominal sepsis on diaphragm function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound measurement of the diaphragm and intercostals
Arm Type
Experimental
Arm Description
The specific research procedures correspond to the addition of : Two additional ultrasound examinations, i.e. at discharge from intensive care and 3 months after hospital discharge: non-invasive examination (duration 20 minutes). Ultrasound is a risk-free, painless procedure involving the placement of an ultrasound probe on the body part under investigation, without the need for a radius or puncture. Questionnaires to assess quality of life (SF-36) and functional impact (LCADL) of dyspnea, carried out at discharge from hospital and at 3 months (duration 15 minutes).
Intervention Type
Other
Intervention Name(s)
Ultrasound measurement of the diaphragm and intercostals
Intervention Description
The specific research procedures correspond to the addition of : Two additional ultrasound examinations, i.e. at discharge from intensive care and 3 months after hospital discharge: non-invasive examination (duration 20 minutes). Ultrasound is a risk-free, painless procedure involving the placement of an ultrasound probe on the body part under investigation, without the need for a radius or puncture. Questionnaires to assess quality of life (SF-36) and functional impact (LCADL) of dyspnea, carried out at discharge from hospital and at 3 months (duration 15 minutes).
Primary Outcome Measure Information:
Title
Diaphragm thickening function
Description
This outcome corresponds to the difference in mean ultrasound diaphragm thickening fraction between ICU discharge and 3 months after hospital discharge.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Function of thickening the diaphragm during inspiratory efforts
Description
This outcome corresponds to the difference in mean between the two groups in the fraction of diaphragm thickening, on ultrasound, within the first 72 hours of admission and on discharge from the intensive care unit.
Time Frame
Month 1
Title
Evolution of diaphragm mobility during inspiratory efforts
Description
This outcome corresponds to the difference in diaphragmatic excursion means within the first 72 hours of admission, at discharge from intensive care and 3 months after hospital discharge.
Time Frame
Month 3
Title
Evolution of intercostal, transversus abdominis and oblique abdominal muscle function
Description
This outcome corresponds to the comparison of thickness of intercostal, transverse and oblique abdominal muscles within the first 72 hours of admission, on discharge from intensive care and 3 months after hospital discharge.
Time Frame
Month 3
Title
Evolution of the cross-sectional area of the rectus femoris on ultrasound
Description
This outcome corresponds to the comparison of the cross-sectional area of the rectus femoris within the first 72 hours of admission, on discharge from the intensive care unit and 3 months after hospital discharge.
Time Frame
Month 3
Title
Evolution of the structure of the various muscle groups assessed by ultrasound
Description
This outcome corresponds to the comparison of gray levels on image captures of different muscle groups using Image J software®.
Time Frame
Month 3
Title
Global measurement of dyspnea
Description
This outcome corresponds to theVAS-Dyspnea comparison (numerical scale from 0 to 10) within the first 72 hours of admission to intensive care, at discharge from intensive care, at discharge from hospital and 3 months after discharge from hospital.
Time Frame
Month 3
Title
Functional impact of dyspnea
Description
This outcome corresponds to london chest activity of daily living scale at hospital discharge (estimate of previous condition) and 3 months after discharge. london chest activity of daily living
Time Frame
Month 3
Title
Short Form-36 Questionnaire of Quality of life
Description
This outcome corresponds to the Short Form-36 comparison at hospital discharge (estimate of previous condition) and 3 months after discharge.
Time Frame
Month 3
Title
Relationship between diaphragm function and dyspnea, and quality of life
Description
This outcome corresponds to the correlation between diaphragm thickening fraction and LCADL scale, SF-36 quality-of-life questionnaire physical score.
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient over 18 years of age, Patient admitted to a critical care unit at Paris Saint-Joseph Hospital, Sepsis or septic shock (defined by the international consensus conference "sepsis-3"), Sepsis/septic shock less than 72 hours old, Patient affiliated to a health insurance scheme, French-speaking patient, Patient or relative who has given free, informed and express consent. Exclusion Criteria: History of documented chronic muscular disease, whatever the cause (neuromuscular damage, abdominal or diaphragmatic hernia, muscular damage of inflammatory origin, myopathies, etc.), Moribund patients, Patient already included in a type 1 interventional research protocol (RIPH1), Patient under guardianship, Patient deprived of liberty, Patient under court protection, Pregnant patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johan WORMSER
Phone
144123085
Ext
+33
Email
jwormser@ghpsj.fr
First Name & Middle Initial & Last Name or Official Title & Degree
François Philippart, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan WORMSER
Organizational Affiliation
Hôpital Paris Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan WORMSER
Phone
144123085
Ext
+33
Email
jwormser@ghpsj.fr

12. IPD Sharing Statement

Citations:
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23641946
Citation
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Evolution of Muscle Function, Breathlessness and Quality of Life Following Intra or Extra-Abdominal Sepsis in ICU Patients

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