Sedation Protocols and Skeletal Muscle Metabolism in Mechanical Ventilated Patients
The Effect of Different Sedation Protocols on Skeletal Muscle Metabolism in Mechanical Ventilated Patients
1 other identifier
interventional
360
1 country
1
Brief 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 group(dexmedetomidine), control group(midazolam) and no sedation group. Serum, CT scan of intercostal muscles, ultrasound evaluation of quadriceps femoris are obtained.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2017
CompletedFirst Submitted
Initial submission to the registry
December 26, 2017
CompletedFirst Posted
Study publicly available on registry
January 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedMarch 29, 2018
December 1, 2017
11 months
December 26, 2017
March 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
acute muscle wasting
measured by 3-MH release in serum
From date of randomization to extubation,up to 7 days
Secondary Outcomes (2)
28-day mortality
From date of randomization to date of death from any cause,up to 28 days
length of ICU stay
From date of randomization to date of to discharge or death,up to 28 days
Study Arms (2)
Dexmedetomidine group
EXPERIMENTALDexmedetomidine consistent infusion as sedative.
Midazolam group
ACTIVE COMPARATORMidazolam consistent infusion as sedative.
Interventions
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.
consistent infusion at a loading dose of 1mg/h, increased by 1mg/h, with a maximum dose of 10mg/h.
Eligibility Criteria
You may qualify if:
- mechanical ventilated for more than 48h
- years
- stay in ICU for more than 5 days
You may not qualify if:
- already participated in other clinical trials
- pregnancy or lactation
- lower limb amputation
- primary neuro-muscular disease
- disseminated tumor or accepted special therapy
- alcohol abuse
- 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）
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2017
First Posted
January 18, 2018
Study Start
December 20, 2017
Primary Completion
October 31, 2018
Study Completion
January 31, 2019
Last Updated
March 29, 2018
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share
Individual participant data is not available to other researchers after publication.