Sedation Protocols and Skeletal Muscle Metabolism in Mechanical Ventilated Patients

NCT ID: NCT03402113

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2019-01-31

Brief Summary

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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

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Conditions

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Hypercatabolism Sedative, Hypnotic, or Anxiolytic Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Dexmedetomidine group

Dexmedetomidine consistent infusion as sedative.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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.

Midazolam group

Midazolam consistent infusion as sedative.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

consistent infusion at a loading dose of 1mg/h, increased by 1mg/h, with a maximum dose of 10mg/h.

Interventions

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Dexmedetomidine

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.

Intervention Type DRUG

Midazolam

consistent infusion at a loading dose of 1mg/h, increased by 1mg/h, with a maximum dose of 10mg/h.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Medical Association

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Affliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenkui Yu, Ph.D

Role: CONTACT

13701582986

Qin Gu, Master

Role: CONTACT

13705150348

Facility Contacts

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Wenkui Yu

Role: primary

02568182222 ext. 60506

Other Identifiers

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Gulou ICU

Identifier Type: -

Identifier Source: org_study_id

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