Sedation Protocols and Skeletal Muscle Metabolism in Mechanical Ventilated Patients

Not Applicable

• Conditions: Hypercatabolism; Sedative, Hypnotic, or Anxiolytic Use Disorders
• Interventions: Drug: Dexmedetomidine; Drug: Midazolam

• Registration Number: NCT03402113
• Lead Sponsor: Chinese Medical Association

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-12
• Study Start: 2017-12-20
• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-18
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-29
• Primary Completion: 2018-10-31
• Study Completion: 2019-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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）

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine	Dexmedetomidine consistent infusion as sedative.
Midazolam group	Midazolam	Midazolam consistent infusion as sedative.

Primary Outcome Measures

Name	Time	Method
acute muscle wasting	From date of randomization to extubation,up to 7 days	measured by 3-MH release in serum

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Affliated Drum Tower Hospital, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China