Back to resultsStudy of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm (SEPTIC)
Primary Purpose
Respiration, Artificial
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
surgery
multi-organ sampling
Sponsored by
About this trial
This is an interventional prevention trial for Respiration, Artificial
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
Sites / Locations
- Croix Rousse Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
control group
sepsis group
mechanical ventilation group
mechanical ventilation - sepsis group
Arm Description
non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy
Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)
Patient in brain death for whom a multi-organ sampling is planned
Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03371602
Brief Title
Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm
Acronym
SEPTIC
Official Title
Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
July 17, 2021 (Actual)
Study Completion Date
July 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration, Artificial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Experimental
Arm Description
non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy
Arm Title
sepsis group
Arm Type
Experimental
Arm Description
Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)
Arm Title
mechanical ventilation group
Arm Type
Experimental
Arm Description
Patient in brain death for whom a multi-organ sampling is planned
Arm Title
mechanical ventilation - sepsis group
Arm Type
Experimental
Arm Description
Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.
Intervention Type
Procedure
Intervention Name(s)
multi-organ sampling
Intervention Description
a diaphragmatic biopsy (100 microgram) will be performed by the surgeon during surgery.
Primary Outcome Measure Information:
Title
Assessment of atrophy of the myofibers of the human diaphragm
Description
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
Time Frame
day 0 (day of the surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline Guichon
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Croix Rousse Hospital
City
Lyon
ZIP/Postal Code
69004
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm
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