Informations générales (source: ClinicalTrials.gov)
Evolution of Muscle Function, Breathlessness and Quality of Life Following Intra or Extra-Abdominal Sepsis in ICU Patients (EMBLemAticS)
Interventional
N/A
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
juillet 2023
décembre 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Johan WORMSER | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.