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Completed

NCT Number: NCT03371602

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Croix Rousse Hospital

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

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

multi-organ sampling

Procedure

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SEPTIC

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 13, 2017
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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