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

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.

Study Overview

• Status: Completed
• Conditions: Respiration, Artificial
• Intervention / Treatment: Procedure: surgery; Procedure: multi-organ sampling

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Croix Rousse Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control group; non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy	Procedure: surgery; a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.
Experimental: sepsis group; Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)	Procedure: surgery; a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.
Experimental: mechanical ventilation group; Patient in brain death for whom a multi-organ sampling is planned	Procedure: multi-organ sampling; a diaphragmatic biopsy (100 microgram) will be performed by the surgeon during surgery.
Experimental: mechanical ventilation - sepsis group; Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)	Procedure: surgery; a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Céline Guichon, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): July 17, 2021
• Study Completion (Actual): July 17, 2021

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: 69HCL15_0423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No