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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371602
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Respiration, Artificial Procedure: surgery Procedure: multi-organ sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm
Actual Study Start Date : June 16, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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.




Primary Outcome Measures :
  1. Assessment of atrophy of the myofibers of the human diaphragm [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371602


Contacts
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Contact: Céline Guichon 4 26 10 92 60 ext +33 celine.guichon@chu-lyon.fr

Locations
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France
Croix Rousse Hospital Recruiting
Lyon, France, 69004
Contact: Céline Guichon    4.26.10.92.60 ext +33      
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Céline Guichon Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03371602    
Other Study ID Numbers: 69HCL15_0423
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes