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

NCT ID: NCT03371602

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-16
• Study Completion Date: 2021-07-17

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.

Conditions

Respiration, Artificial

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

control group

non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy

Group Type: EXPERIMENTAL

surgery

Intervention Type: PROCEDURE

a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.

sepsis group

Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)

Group Type: EXPERIMENTAL

surgery

Intervention Type: PROCEDURE

a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.

mechanical ventilation group

Patient in brain death for whom a multi-organ sampling is planned

Group Type: EXPERIMENTAL

multi-organ sampling

Intervention Type: PROCEDURE

a diaphragmatic biopsy (100 microgram) will be performed by the surgeon during surgery.

mechanical ventilation - sepsis group

Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)

Group Type: EXPERIMENTAL

surgery

Intervention Type: PROCEDURE

a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.

Interventions

surgery

a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.

Intervention Type: PROCEDURE

multi-organ sampling

a diaphragmatic biopsy (100 microgram) will be performed by the surgeon during surgery.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Céline Guichon

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Croix Rousse Hospital

Lyon, , France

Countries

France

Other Identifiers

69HCL15_0423

Identifier Type: -

Identifier Source: org_study_id