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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03371602
Acronym
SEPTIC
Enrollment
33
Registered
2017-12-13
Start date
2017-06-16
Completion date
2021-07-17
Last updated
2023-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration, Artificial

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.

Interventions

PROCEDUREsurgery

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

PROCEDUREmulti-organ sampling

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of atrophy of the myofibers of the human diaphragmday 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026