Septic ShockµARNNCT02464371
Interest of Plasma microRNAs
An observational study of Septic Shock, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
ICU acquired muscle weakness (IAMW) is a common disease that is associated with high morbidity and mortality. Patients with septic shock are particularly at risk. The diagnosis of IAMW is clinical and based on the rating of the Medical Research Council score (MRC score). A MRC score lower than 48 defines the IAMW. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- kinetic of microRNAs
- How many people
- 58 participants
- Where
- 2 sitesFrance
- Study dates
- May 2015to 13 May 2017
- Phase
- Observational
- 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
Study population: septic shock patients admitted into ICU.
Who may be able to join
- Patients with septic shock criteria:
- At least two of the following criteria: temperature < 36 ° C or > 38 ° C, heart rate > 90 beats / minute, respiratory rate> 20 breaths / minute or PaCO2 < 32mmHg, leukocytes > 12,000 / mm3 or < 4000 / mm3
- Refractory Hypotension (blood pressure < 90mmHg or need norepinephrine) or lactate ≥ 4 mmol / L
Who cannot join
- Age<18years
- Patients with preexisting neuromuscular disease
- Pregnancy
- Moribund patients with early therapeutic limitation
- Patients who had a seizure in the last 6 months
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Interest of Plasma microRNAs Assay in ICU Acquired Muscle Weakness Diagnosis
ICU acquired muscle weakness (IAMW) is a common disease that is associated with high morbidity and mortality. Patients with septic shock are particularly at risk.
The diagnosis of IAMW is clinical and based on the rating of the Medical Research Council score (MRC score). A MRC score lower than 48 defines the IAMW. But this evaluation is only usable in sufficiently awaken patients.
Read more
Several studies have highlighted the role of microRNAs in regulating physiological processes and diseases related to the skeletal muscles. To date, no study was interested in IAMW.
The aim of this study is to compare the microRNA detection kinetics on the appearance of IAMW.
In septic shock patients, the kinetics of nine microRNAs will be compared between two groups: those with IAMW (IAMW + group) and those without IAMW (IAMW - group).
Read the detailed description
MicroRNAs (miR-1, miR-21, miR-133, miR-155, miR-206, miR-208a, miR-208b, miR-486, miR-499) will be measured at day 1, day 2, day 5 and day 7 after septic shock onset.
- Conditions
- Septic Shock
- Being tested
- kinetic of microRNAs
- Keywords
- muscle weakness, microRNAs, septic shock
- Medical subject headings
- Shock, Septic, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinetic of microRNAsOther
blood samples will be drawn to measure microRNAs
| Study group | Role | What they receive |
|---|---|---|
| ICU acquired muscle weakness (IAMW) group + | The Medical Research Council score (MRC score) is lower than 48, defining an ICU acquired muscle weakness (IAMW).
Kinetic of microRNAs is measured Receives: Other: kinetic of microRNAs | |
| ICU acquired muscle weakness (IAMW) group - | The Medical Research Council score (MRC score) is higher than 48. Kinetic of microRNAs is measured Receives: Other: kinetic of microRNAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Values of microRNAs between day 1 and day 7
Values of microRNAs measured between day 1 and day 7 in the 2 groups (IAMW+ group and IAMW- group).
Measured: Day 7
Secondary outcomes (4)
predictive threshold of evolution to the IAMW
From the values of each microRNAs measured at D1, D3, D5 and D7, a predictive threshold of evolution to the IAMW will be sought by the analysis of a ROC curve. The kinetics of microRNAs will be compared between survivors and non-survivors at the discharge.
Measured: Day 1
predictive threshold of evolution to the IAMW
From the values of each microRNAs measured at D1, D3, D5 and D7, a predictive threshold of evolution to the IAMW will be sought by the analysis of a ROC curve. The kinetics of microRNAs will be compared between survivors and non-survivors at the discharge.
Measured: Day 3
predictive threshold of evolution to the IAMW
From the values of each microRNAs measured at D1, D3, D5 and D7, a predictive threshold of evolution to the IAMW will be sought by the analysis of a ROC curve. The kinetics of microRNAs will be compared between survivors and non-survivors at the discharge.
Measured: Day 5
predictive threshold of evolution to the IAMW
From the values of each microRNAs measured at D1, D3, D5 and D7, a predictive threshold of evolution to the IAMW will be sought by the analysis of a ROC curve. The kinetics of microRNAs will be compared between survivors and non-survivors at the discharge.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion3 May 2017
- Study completion13 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerome MOREL, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464371
- Sponsor's protocol ID
- 1508014
- Acronym
- µARN
- Status last verified
- May 2017
- First submitted
- 2 Jun 2015
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Plasma microRNAs Assay in ICU Acquired Muscle Weakness Diagnosis
- ClinicalTrials.gov ID
- NCT02464371
- Acronym / sponsor ID
- µARN / 1508014
- Conditions
- Septic Shock
- Keywords
- muscle weakness, microRNAs, septic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 13 May 2017 (actual)
- First posted
- 8 Jun 2015 (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.
ICU acquired muscle weakness (IAMW) is a common disease that is associated with high morbidity and mortality. Patients with septic shock are particularly at risk.
The diagnosis of IAMW is clinical and based on the rating of the Medical Research Council score (MRC score). A MRC score lower than 48 defines the IAMW. But this evaluation is only usable in sufficiently awaken patients.
Several studies have highlighted the role of microRNAs in regulating physiological processes and diseases related to the skeletal muscles. To date, no study was interested in IAMW.
The aim of this study is to compare the microRNA detection kinetics on the appearance of IAMW.
In septic shock patients, the kinetics of nine microRNAs will be compared between two groups: those with IAMW (IAMW + group) and those without IAMW (IAMW - group).
Detailed description
MicroRNAs (miR-1, miR-21, miR-133, miR-155, miR-206, miR-208a, miR-208b, miR-486, miR-499) will be measured at day 1, day 2, day 5 and day 7 after septic shock onset.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU acquired muscle weakness (IAMW) group + | – | Other: kinetic of microRNAsThe Medical Research Council score (MRC score) is lower than 48, defining an ICU acquired muscle weakness (IAMW). Kinetic of microRNAs is measured |
| ICU acquired muscle weakness (IAMW) group - | – | Other: kinetic of microRNAsThe Medical Research Council score (MRC score) is higher than 48. Kinetic of microRNAs is measured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- septic shock patients admitted into ICU.
Key inclusion criteria (3 listed)
- At least two of the following criteria: temperature < 36 ° C or > 38 ° C, heart rate > 90 beats / minute, respiratory rate> 20 breaths / minute or PaCO2 < 32mmHg, leukocytes > 12,000 / mm3 or < 4000 / mm3
- Refractory Hypotension (blood pressure < 90mmHg or need norepinephrine) or lactate ≥ 4 mmol / L
Key exclusion criteria (5 listed)
- Age<18years
- Patients with preexisting neuromuscular disease
- Pregnancy
- Moribund patients with early therapeutic limitation
- Patients who had a seizure in the last 6 months
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 |
|---|---|---|
| kinetic of microRNAsblood samples will be drawn to measure microRNAs | Other | ICU acquired muscle weakness (IAMW) group +, ICU acquired muscle weakness (IAMW) group - |
Primary outcome
Values of microRNAs between day 1 and day 7
Time frame: Day 7
Values of microRNAs measured between day 1 and day 7 in the 2 groups (IAMW+ group and IAMW- group).
4 secondary outcomes
predictive threshold of evolution to the IAMW
Time frame: Day 1
predictive threshold of evolution to the IAMW
Time frame: Day 3
predictive threshold of evolution to the IAMW
Time frame: Day 5
predictive threshold of evolution to the IAMW
Time frame: Day 7
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 16 May 2017.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
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.
Jerome MOREL, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites 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 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: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Values of microRNAs between day 1 and day 7 (time frame: Day 7). 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 16 May 2017.