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CompletedNCT01976754Updated Mar 22, 2022

Safety Study of Dexmedetomidine in Septic Patients

An interventional study of Dexmedetomidine in Sepsis and Agitation, sponsored by First Affiliated Hospital of Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-22.

Sponsored by First Affiliated Hospital of Zhejiang University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Septic patients in Intensive Care Unit always need mechanical ventilation and conscious-sedation. But the recommended dose 0.2-0.7μg/kg/h could not run well because of wide range. The purpose of this study is to find the effective dose of dexmedetomidine adult septic patients of mechanical ventilation .

Read the detailed description

Inclusion Criteria:

Age: between 18 years mechanical ventilation RASS≥2 A diagnosis of sepsis within 48 hours

Exclusion Criteria:

Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users

Primary Outcome Measures:

Dose of dexmedetomidine

Secondary Outcome Measures:

RASS score Requirement for rescue intervention, RASS will be recorded per hour.

02

Conditions studied

  • Sepsis
  • Agitation
03

In context

Sepsis

1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.

This study's planned enrollment of 40 is below the median of 105 across 918 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 260 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • intubated patients RASS≥2 A diagnosis of sepsis within 48h

Exclusion criteria

Exclusion Criteria:

  • Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Other
    dexmedetomidine,sepsis,ED50

    Intervention Name: dexmedetomidine dosage form: intravenous injection dosage:0.2-0.7μg/kg/h frequency: 1 duration:12 hours

    Drug: Dexmedetomidine

Interventions

  • Septic patients are randomly received 1 of 6 doses( 0.2,0.3,0.4,0.5,0.6,0.7μg/kg/h) dexmedetomidine.

    Also known as: precedex

06

What researchers measure

Primary outcomes

  1. Dose of dexmedetomidine

    Time frame: 12 hours

Secondary outcomes

  1. RASS score Requirement for rescue intervention, RASS will be recorded per hour.

    Time frame: 1 hour

07

Study locations

1 site
  • Zhanqin Zhang
    Hangzhou, Zhejiang 310000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01976754
Responsible party
zhanqin zhang (PHD candidate, First Affiliated Hospital of Zhejiang University) — Principal investigator
First posted
Nov 6, 2013
Start date
Sep 2013
Primary completion
Mar 2015
Completion
Jul 2015
Last update
Mar 22, 2022

Study contacts

xiangming fang, PHD
principal investigator · First Affiliated Hospital of Zhejiang University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Dexmedetomidine

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