CClinicalTrials.gg
Status unknownNCT03402113Updated Mar 29, 2018

Sedation Protocols and Skeletal Muscle Metabolism in Mechanical Ventilated Patients

An interventional study of Dexmedetomidine and Midazolam in Hypercatabolism and Sedative, Hypnotic, or Anxiolytic Use Disorders, sponsored by Chinese Medical Association. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Chinese Medical Association · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypercatabolism
  • Sedative, Hypnotic, or Anxiolytic Use Disorders
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • mechanical ventilated for more than 48h
  • 18-80 years
  • stay in ICU for more than 5 days

Exclusion criteria

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
360 participants (estimated)

Study arms

  • Experimental
    Dexmedetomidine group

    Dexmedetomidine consistent infusion as sedative.

    Drug: Dexmedetomidine

  • Active comparator
    Midazolam group

    Midazolam consistent infusion as sedative.

    Drug: Midazolam

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.

05

What researchers measure

Primary outcomes

  1. acute muscle wasting

    measured by 3-MH release in serum

    Time frame: From date of randomization to extubation,up to 7 days

Secondary outcomes

  1. 28-day mortality

    death rate within 28 days after mechanical ventilation

    Time frame: From date of randomization to date of death from any cause,up to 28 days

  2. length of ICU stay

    time from enrollment to discharge or die

    Time frame: From date of randomization to date of to discharge or death,up to 28 days

06

Study locations

1 of 1 sites recruiting
  • The Affliated Drum Tower Hospital, Medical School of Nanjing University
    Nanjing, Jiangsu 210008, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Individual participant data is not available to other researchers after publication.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03402113
Lead sponsor
Chinese Medical Association
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
Dec 20, 2017
Primary completion
Oct 31, 2018 (estimated)
Completion
Jan 31, 2019 (estimated)
Last update
Mar 29, 2018

Study contacts

Wenkui Yu, Ph.D
Contact
yudrnj@163.com
13701582986
Qin Gu, Master
Contact
icuguqin@sina.com
13705150348

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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