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

Not Applicable

Completed

• Conditions: Respiration, Artificial
• Interventions: Procedure: multi-organ sampling; Procedure: surgery

• Registration Number: NCT03371602
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-16
• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-13
• Primary Completion: 2021-07-17
• Study Completion: 2021-07-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mechanical ventilation group	multi-organ sampling	Patient in brain death for whom a multi-organ sampling is planned
sepsis group	surgery	Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)
control group	surgery	non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy
mechanical ventilation - sepsis group	surgery	Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)

Primary Outcome Measures

Name	Time	Method
Assessment of atrophy of the myofibers of the human diaphragm	day 0 (day of the surgery)	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

Trial Locations

Locations (1)

Croix Rousse Hospital; 🇫🇷 Lyon, France