Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm

Respiration, Artificial Clinical Trial

— SEPTIC  

Official title:

Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371602
• Other study ID #: 69HCL15_0423
• Status: Completed
• Phase: N/A
• Start date: June 16, 2017
• Est. completion date: July 17, 2021

Study information

• Verified date: July 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to study the combined impact of mechanical ventilation and sepsis on the human diaphragm in order to establish the neutral, protective or destructive character of mechanical ventilation by studying the diameter of the fibers, activation of proteolytic systems, inhibition of protein synthesis, tissue inflammation as well as contractile function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 17, 2021
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient at least 18 years of age, male or female requiring abdominal or thoracic surgery or multi-organ sampling;

• Affiliated to a social security or similar system;

• Not subject to legal protection;

• Having given consent to participate in the study (or consent from the trusted person)

• Control group (C): non-septic mesocolic programmed abdominal or thoracic surgery:

gastrectomy, esophagectomy, pancreatectomy, hepatectomy

• Sepsis group (S): Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)

• Group Mechanical Ventilation (MV): Patient in brain death for which a multi organ sample is planned

• Mechanical Ventilation + Sepsis (S-MV) group: Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)

Exclusion Criteria:

• Pregnant woman (diagnosis of interrogation)

• severe and / or unbalanced chronic respiratory disease; severe malnutrition

• Long-term corticosteroids> 5mg / day for more than 1 month

• Myopathy

• surgery by laparoscopic

By group:

• Control group: Sepsis, preoperative controlled mechanical ventilation and preoperative hemodynamic instability

• Mechanical Ventilation Group: Sepsis, duration of controlled mechanical ventilation <24 hours or> 7 days

• Sepsis Group: Preoperatively controlled mechanical ventilation

• Mechanical Ventilation - Sepsis Group: duration of controlled mechanical ventilation <24 hours or> 7 days

Related Conditions & MeSH terms

• Respiration, Artificial
• Sepsis

Intervention

Procedure:
• surgery
a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.
• multi-organ sampling
a diaphragmatic biopsy (100 microgram) will be performed by the surgeon during surgery.

Locations

Country	Name	City	State
France	Croix Rousse Hospital	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of atrophy of the myofibers of the human diaphragm	Atrophy of the myofibers will be assessed by comparison of the cross sectional area of the three different types of myofibers between the sepsis-mechanical ventilation group and the sepsis group, the ventilation group and the control group	day 0 (day of the surgery)