Dex on Microcirculation in SS-A Double-blinded Study

NCT ID: NCT02612181

Last Updated: 2017-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Dexmedetomidine for dexmedetomidine group

Intervention Type DRUG

The effect of dex and placebo for sedation on microcirculation

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

Group Type PLACEBO_COMPARATOR

Dexmedetomidine for dexmedetomidine group

Intervention Type DRUG

The effect of dex and placebo for sedation on microcirculation

Interventions

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Dexmedetomidine for dexmedetomidine group

The effect of dex and placebo for sedation on microcirculation

Intervention Type DRUG

Other Intervention Names

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Placebo for control group

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Jingyuan,Xu

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jingyuan Xu, M.D.

Role: CONTACT

862586232550

Facility Contacts

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Jingyuan Xu, M.D.

Role: primary

862586232550

Other Identifiers

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2015ZDSYLL016.1

Identifier Type: -

Identifier Source: org_study_id

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