CClinicalTrials.gg
Status unknownNCT02612181Updated Jun 15, 2017

Dex on Microcirculation in SS-A Double-blinded Study

A Phase 4 interventional study of Dexmedetomidine for dexmedetomidine group in Septic Shock, sponsored by Southeast University, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-06-15.

Sponsored by Southeast University, China · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. To test this effect, the investigators will conduct double-blinded study.

Read the detailed description

Dexmedetomidine is a highly selective α2-adrenoreceptor agonist for sedation of adult critically ill patients which exhibits sedative and analgesic effects. Recent studies suggest that dexmedetomidine to restore adrenergic vasoconstrictor responsiveness in septic shock, and prevents alterations of pain rat model intestinal microcirculation Induced by surgical stress,even it can reduce the mortality of endotoxemic rats and patients with severe sepsis. The investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. To test this effect, the investigators will conduct double-blinded study.

02

Conditions studied

  • Septic Shock

Keywords

  • dexmedetomidine
  • microcirculation
  • septic shock
03

In context

Shock, Septic

862 studies on the registry are indexed under Shock, Septic; 206 are open to participants now.

This study's planned enrollment of 44 is below the median of 79 across 529 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Septic shock patients despite early goal directed therapy
  • Agree to participate this study

Exclusion criteria

Exclusion Criteria:

  • Age\< 18
  • Pregnancy
  • Bradycardia (HR\<55bpm)
  • Systolic Blood Pressure \< 80 mmHg / Mean arterial pressure \< 50 mmHg on maximal support
  • Death imminent
  • Unlikely to survive 90 days
  • Acute liver failure
  • Dementia
  • High-grade block in the absence of a functioning pacemaker.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Dexmedetomidine group

    Dexmedetomidine group: Dexmedetomidine infusion for dexmedetomidine group to the goal of sedation: Richmond agitation-sedation scale 0 to -2 Dexmedetomidine doses 0-0.7 mcg/kg/h

    Drug: Dexmedetomidine for dexmedetomidine group

  • Placebo comparator
    Control group

    Control group: Placebo infusion for control group to the goal of sedation: Richmond agitation-sedation scale 0 to -2 Control drug doses 0-0.7 mcg/kg/h

    Drug: Dexmedetomidine for dexmedetomidine group

Interventions

  • DrugDexmedetomidine for dexmedetomidine group

    The effect of dex and placebo for sedation on microcirculation

    Also known as: Placebo for control group

06

What researchers measure

Primary outcomes

  1. Microcirculatory function as assessed by Microvascular flow index

    sedation for 30 minutes then monitor the microcirculation

    Time frame: 30 minutes

07

Study locations

1 of 1 sites recruiting
  • Zhongda Hospital Southeast University
    Nanjing, Jiangsu 210000, China
    • Jingyuan Xu, M.D. · Contact · xujingyuanmail@163.com · 862586232550
    • Jingyuan Xu, M.D. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02612181
Lead sponsor
Southeast University, China
Responsible party
Jingyuan,Xu (Principal investigator, Southeast University, China) — Principal investigator
First posted
Nov 23, 2015
Start date
Jan 2016
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Jun 15, 2017

Study contacts

Jingyuan Xu, M.D.
Contact
xujingyuanmail@163.com
862586232550

Oversight

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

Not currently enrolling

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

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