Hypercatabolism, Sedative, Hypnotic, or Anxiolytic Use Disorders
Conditions
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.
Interventions
DRUGDexmedetomidine
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.
DRUGMidazolam
consistent infusion at a loading dose of 1mg/h, increased by 1mg/h, with a maximum dose of 10mg/h.
Sponsors
Chinese Medical Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* mechanical ventilated for more than 48h * 18-80 years * stay in ICU for more than 5 days
Exclusion criteria
* 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）
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute muscle wasting | From date of randomization to extubation,up to 7 days | measured by 3-MH release in serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | From date of randomization to date of death from any cause,up to 28 days | death rate within 28 days after mechanical ventilation |
| length of ICU stay | From date of randomization to date of to discharge or death,up to 28 days | time from enrollment to discharge or die |
Countries
China
Contacts
Primary ContactWenkui Yu, Ph.D
Backup ContactQin Gu, Master
Outcome results
None listed