SepsisNCT01104857
Respiratory Muscle Dysfunction in Critically Ill Patients
A study testing diaphragm muscle biopsy in people with Sepsis and Mechanical Ventilation, run by University Medical Center Nijmegen at 1 site in Netherlands.
Trial summary
Respiratory muscle dysfunction in critically ill patients is associated with elevated morbidity, including prolonged weaning from mechanical ventilation. The causes for respiratory muscle dysfunction in these patients is poorly understood and no effective treatment is available. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Mechanical Ventilation
- What is being tested?
- diaphragm muscle biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Apr 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe sepsis / septic shock
- Clinical reason for laparotomy
- > 18 years
Who cannot join
- No informed consent
- Medical history of myopathy
- Unintended weight loss before ICU admission
- Pregnancy
- Chronic use of corticosteroids
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud Universtity Nijmegen Medical Centre
Nijmegen, 6500HB
About this study
Respiratory muscle dysfunction in critically ill patients is associated with elevated morbidity, including prolonged weaning from mechanical ventilation. The causes for respiratory muscle dysfunction in these patients is poorly understood and no effective treatment is available.
The general hypothesis of the present study is that in critically ill mechanically ventilated subjects respiratory muscle dysfunctions results from loss of myosin induced by activation of proteolytic cascades.
- Conditions
- Sepsis, Mechanical Ventilation
- Being tested
- diaphragm muscle biopsy
- Keywords
- Respiratory muscle, Myosin, Mechanical ventilation
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragm muscle biopsyProcedure or surgery
Biopsy is obtained for biochemical analysis
Diaphragm muscle biopsyProcedure or surgery
Biopsy is obtained for biochemical analysis
| Study group | Role | What they receive |
|---|---|---|
| Diaphragm muscle biopsy | Experimental | Patients admitted to the ICU meeting severe sepsis / septic shock criteria Receives: Procedure: diaphragm muscle biopsy |
| Elective laparotomy | Active comparator | Not described Receives: Procedure: Diaphragm muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm muscle myosin content
Measured: 1 day
Markers for inflammation
Inflammatory mediators are measured in plasma and diaphragm at the moment the diaphragm biopsy is obtained.
Measured: 1 day
Markers for activation of proteolytic pathway in the diaphragm
Biochemical analysis is targeted towards activation of several proteolytic pathways (proteasome, lysosmal).
Measured: 1 day
Secondary outcomes (2)
length of ICU stay
Length of ICU stay obtained from medical record
Measured: 6 months
Length of mechanical ventilation
Duration of mechanical ventilation is assesssed within 6 months after obtaining diaphragm biopsy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leo Heunks, University Medical Center Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104857
- Sponsor's protocol ID
- Diam1
- Status last verified
- Jun 2015
- First submitted
- 12 Apr 2010
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Dysfunction in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01104857
- Acronym / sponsor ID
- Diam1
- Conditions
- Sepsis, Mechanical Ventilation
- Keywords
- Respiratory muscle, Myosin, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 16 Apr 2010 (estimated)
- 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.
Respiratory muscle dysfunction in critically ill patients is associated with elevated morbidity, including prolonged weaning from mechanical ventilation. The causes for respiratory muscle dysfunction in these patients is poorly understood and no effective treatment is available.
The general hypothesis of the present study is that in critically ill mechanically ventilated subjects respiratory muscle dysfunctions results from loss of myosin induced by activation of proteolytic cascades.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragm muscle biopsy | Experimental | Procedure: diaphragm muscle biopsyPatients admitted to the ICU meeting severe sepsis / septic shock criteria |
| Elective laparotomy | Active comparator | Procedure: Diaphragm muscle biopsy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe sepsis / septic shock
- Clinical reason for laparotomy
- > 18 years
Key exclusion criteria (5 listed)
- No informed consent
- Medical history of myopathy
- Unintended weight loss before ICU admission
- Pregnancy
- Chronic use of corticosteroids
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 |
|---|---|---|
| diaphragm muscle biopsyBiopsy is obtained for biochemical analysis | Procedure or surgery | Diaphragm muscle biopsy |
| Diaphragm muscle biopsyBiopsy is obtained for biochemical analysis | Procedure or surgery | Elective laparotomy |
Primary outcome
Diaphragm muscle myosin content
Time frame: 1 day
Markers for inflammation
Time frame: 1 day
Inflammatory mediators are measured in plasma and diaphragm at the moment the diaphragm biopsy is obtained.
Markers for activation of proteolytic pathway in the diaphragm
Time frame: 1 day
Biochemical analysis is targeted towards activation of several proteolytic pathways (proteasome, lysosmal).
2 secondary outcomes
length of ICU stay
Time frame: 6 months
Length of mechanical ventilation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diaphragm muscle biopsy in people with Sepsis and Mechanical Ventilation, run by University Medical Center Nijmegen at 1 site in Netherlands.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Jun 2015. 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 Netherlands. 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?
Results are not available in the source record.
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?
Diaphragm muscle myosin content (time frame: 1 day). The study lists 3 primary outcomes in all. 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 10 Jun 2015.