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

NCT03371602 | Completed

• 1 other identifier: 69HCL15_0423
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (4)

control group

EXPERIMENTAL

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

Procedure: surgery

sepsis group

EXPERIMENTAL

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

Procedure: surgery

mechanical ventilation group

EXPERIMENTAL

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

Procedure: multi-organ sampling

mechanical ventilation - sepsis group

EXPERIMENTAL

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

Procedure: surgery

Interventions

surgery PROCEDURE

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

control group; mechanical ventilation - sepsis group; sepsis group

multi-organ sampling PROCEDURE

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

mechanical ventilation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Croix Rousse Hospital

Lyon, 69004, France

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Céline Guichon

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: December 13, 2017
• Study Start: June 16, 2017
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)