NCT01976754

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

March 22, 2022

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

October 23, 2013

Last Update Submit

March 21, 2022

Conditions

SepsisAgitation

Outcome Measures

Primary Outcomes (1)

  • Dose of dexmedetomidine

    12 hours

Secondary Outcomes (1)

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

    1 hour

Study Arms (1)

dexmedetomidine,sepsis,ED50

OTHER

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

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

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
dexmedetomidine,sepsis,ED50

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhanqin Zhang

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

SepsisPsychomotor Agitation

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • xiangming fang, PHD

    First Affiliated Hospital of Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD candidate

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 6, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2015

Study Completion

July 1, 2015

Last Updated

March 22, 2022

Record last verified: 2016-02

Locations

CN(1)