Evolution of Muscle Function, Breathlessness and Quality of Life Following Intra or Extra-Abdominal Sepsis in ICU Patients - Trial NCT06010186

Timeline & Enrollment

Primary Outcome

Diaphragm thickening function

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.

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