Respiration, ArtificialSEPTICNCT03371602
Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm
A study testing surgery and multi-organ sampling in people with Respiration, Artificial, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- surgery and multi-organ sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2017to 17 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Respiration, Artificial
- Being tested
- surgery, multi-organ sampling
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.
multi-organ samplingProcedure or surgery
a diaphragmatic biopsy (100 microgram) will be performed by the surgeon during surgery.
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy Receives: Procedure: surgery |
| sepsis group | Experimental | Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess) Receives: Procedure: surgery |
| mechanical ventilation group | Experimental | Patient in brain death for whom a multi-organ sampling is planned Receives: Procedure: multi-organ sampling |
| mechanical ventilation - sepsis group | Experimental | Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess) Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 0 (day of the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start16 Jun 2017
- Primary completion17 Jul 2021
- Study completion17 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Guichon, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371602
- Sponsor's protocol ID
- 69HCL15_0423
- Acronym
- SEPTIC
- Status last verified
- Jul 2023
- First submitted
- 3 Oct 2017
- Last updated
- 7 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm
- ClinicalTrials.gov ID
- NCT03371602
- Acronym / sponsor ID
- SEPTIC / 69HCL15_0423
- Conditions
- Respiration, Artificial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 17 Jul 2021 (actual)
- Study completion
- 17 Jul 2021 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Procedure: surgerynon-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy |
| sepsis group | Experimental | Procedure: surgeryAbdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess) |
| mechanical ventilation group | Experimental | Procedure: multi-organ samplingPatient in brain death for whom a multi-organ sampling is planned |
| mechanical ventilation - sepsis group | Experimental | Procedure: surgeryPatient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgerya diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery. | Procedure or surgery | control group, mechanical ventilation - sepsis group, sepsis group |
| multi-organ samplinga diaphragmatic biopsy (100 microgram) will be performed by the surgeon during surgery. | Procedure or surgery | mechanical ventilation group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline Guichon principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery and multi-organ sampling in people with Respiration, Artificial, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of atrophy of the myofibers of the human diaphragm (time frame: day 0 (day of the surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.