Sedation Protocols and Skeletal Muscle Metabolism in Mechanical Ventilated Patients

March 26, 2018 updated by: Chinese Medical Association

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wenkui Yu, Ph.D
  • Phone Number: 13701582986
  • Email: yudrnj@163.com

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • The Affliated Drum Tower Hospital, Medical School of Nanjing University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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）

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine group
Dexmedetomidine consistent infusion as sedative.
Drug: 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.
Active Comparator: Midazolam group
Midazolam consistent infusion as sedative.
Drug: Midazolam
consistent infusion at a loading dose of 1mg/h, increased by 1mg/h, with a maximum dose of 10mg/h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute muscle wasting
Time Frame: From date of randomization to extubation,up to 7 days
measured by 3-MH release in serum
From date of randomization to extubation,up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: From date of randomization to date of death from any cause,up to 28 days
death rate within 28 days after mechanical ventilation
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
time from enrollment to discharge or die
From date of randomization to date of to discharge or death,up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Medical Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2017

Primary Completion (Anticipated)

October 31, 2018

Study Completion (Anticipated)

January 31, 2019

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 26, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gulou ICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data is not available to other researchers after publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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