HypercatabolismNCT03402113
Sedation Protocols and Skeletal Muscle Metabolism in Mechanical Ventilated Patients
A study testing Dexmedetomidine and Midazolam in people with Hypercatabolism and Sedative, Hypnotic, or Anxiolytic Use Disorders, run by Chinese Medical Association at 1 site in China.
Trial summary
To investigate the effects of different sedation protocols on skeletal muscle metabolism in mechanical ventilated patients in ICU. Mechanical ventilated patients who are anticipated to stay in ICU for more than 5 days are enrolled and randomly assigned to the following three groups, interventional… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercatabolism, Sedative, Hypnotic, or Anxiolytic Use Disorders
- What is being tested?
- Dexmedetomidine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2017to 31 Jan 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mechanical ventilated for more than 48h
- 18-80 years
- stay in ICU for more than 5 days
Who cannot join
- already participated in other clinical trials
- pregnancy or lactation
- lower limb amputation
- primary neuro-muscular disease
- disseminated tumor or accepted special therapy
- alcohol abuse
Show all 13Show fewer
- severe liver dysfunction(Child-Push C)
- unstable angina/acute myocardial infarction
- heart rates<50bpm
- all kinds dialysis
- severe burn
- epidural anesthesia
- severe neurological disease（acute stroke, uncontrollable epilepsy, severe dementia, etc）
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008
Wenkui Yu, 02568182222 ext. 60506, yudrnj@163.com
About this study
Official title: The Effect of Different Sedation Protocols on Skeletal Muscle Metabolism in Mechanical Ventilated Patients
To investigate the effects of different sedation protocols on skeletal muscle metabolism in mechanical ventilated patients in ICU. Mechanical ventilated patients who are anticipated to stay in ICU for more than 5 days are enrolled and randomly assigned to the following three groups, interventional group(dexmedetomidine), control group(midazolam) and no sedation group. Serum, CT scan of intercostal muscles, ultrasound evaluation of quadriceps femoris are obtained.
- Being tested
- Dexmedetomidine, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
consistent infusion at a loading dose of 0.15ug/kg/h, increased by 0.15ug/kg/h, with a maximum dose of 1.5ug/kg/h.
MidazolamDrug
consistent infusion at a loading dose of 1mg/h, increased by 1mg/h, with a maximum dose of 10mg/h.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Dexmedetomidine consistent infusion as sedative. Receives: Drug: Dexmedetomidine |
| Midazolam group | Active comparator | Midazolam consistent infusion as sedative. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute muscle wasting
measured by 3-MH release in serum
Measured: From date of randomization to extubation,up to 7 days
Secondary outcomes (2)
28-day mortality
death rate within 28 days after mechanical ventilation
Measured: From date of randomization to date of death from any cause,up to 28 days
length of ICU stay
time from enrollment to discharge or die
Measured: From date of randomization to date of to discharge or death,up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start20 Dec 2017
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercatabolismStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402113
- Sponsor's protocol ID
- Gulou ICU
- Status last verified
- Dec 2017
- First submitted
- 26 Dec 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is not available to other researchers after publication.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Sedation Protocols on Skeletal Muscle Metabolism in Mechanical Ventilated Patients
- ClinicalTrials.gov ID
- NCT03402113
- Acronym / sponsor ID
- Gulou ICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 18 Jan 2018 (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.
To investigate the effects of different sedation protocols on skeletal muscle metabolism in mechanical ventilated patients in ICU. Mechanical ventilated patients who are anticipated to stay in ICU for more than 5 days are enrolled and randomly assigned to the following three groups, interventional group(dexmedetomidine), control group(midazolam) and no sedation group. Serum, CT scan of intercostal muscles, ultrasound evaluation of quadriceps femoris are obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineDexmedetomidine consistent infusion as sedative. |
| Midazolam group | Active comparator | Drug: MidazolamMidazolam consistent infusion as sedative. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mechanical ventilated for more than 48h
- 18-80 years
- stay in ICU for more than 5 days
Key exclusion criteria (13 listed)
- already participated in other clinical trials
- pregnancy or lactation
- lower limb amputation
- primary neuro-muscular disease
- disseminated tumor or accepted special therapy
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 |
|---|---|---|
| Dexmedetomidineconsistent infusion at a loading dose of 0.15ug/kg/h, increased by 0.15ug/kg/h, with a maximum dose of 1.5ug/kg/h. | Drug | Dexmedetomidine group |
| Midazolamconsistent infusion at a loading dose of 1mg/h, increased by 1mg/h, with a maximum dose of 10mg/h. | Drug | Midazolam group |
Primary outcome
acute muscle wasting
Time frame: From date of randomization to extubation,up to 7 days
measured by 3-MH release in serum
2 secondary outcomes
28-day mortality
Time frame: From date of randomization to date of death from any cause,up to 28 days
length of ICU stay
Time frame: From date of randomization to date of to discharge or death,up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No. Individual participant data is not available to other researchers after publication.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Midazolam in people with Hypercatabolism and Sedative, Hypnotic, or Anxiolytic Use Disorders, run by Chinese Medical Association at 1 site in China.
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 13 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 29 Mar 2018. 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 China. 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?
Contact Wenkui Yu, Ph.D (13701582986, yudrnj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute muscle wasting (time frame: From date of randomization to extubation,up to 7 days). 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 29 Mar 2018.