Dexmedetomidine on Microcirculation in Septic Shock

December 10, 2018 updated by: Jingyuan,Xu, Southeast University, China

Dexmedetomidine Improve Microcirculatory Alterations in Initial Resuscitated Septic Shock Patients

Dexmedetomidine was found might be beneficial to sepsis. Dexmedetomidine were found to improve microcirculation in sepsis animal studies and non-sepsis patients. However, the effect of dexmedetomidine on microcirculation in septic shock patients is unknown.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Septic shock is characterized by significant decline in vascular response and relative hypovolemia. Fluids and exogenous catecholamines are mainstay. However, even after initial resuscitation, microcirculatory dysfunctions still exist, and represent a direct physiologic link to organ failure and death. Therefore, therapeutic strategies aiming at improving microcirculation are performed.

Dexmedetomidine was found might be beneficial to sepsis. Dexmedetomidine were found to improve microcirculation in sepsis animal studies and non-sepsis patients. However, the effect of dexmedetomidine on microcirculation in septic shock patients is unknown.

Based on the hypothesis that dexmedetomidine might improve microcirculation in initial resuscitated septic shock patients, the study was to investigate the effects of dexmedetomidine on microcirculation in early septic shock patients despite initial resuscitation. Meanwhile, to observe the possible mechanism of the effect, the correlation between dexmedetomidine dose and microcirculatory parameters as well as catecholamine level were performed.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Zhongda Hospital Southeast University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Adult patients who met the following inclusion criteria were enrolled in the study: 1) With septic shock defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference for less than 24 hours.

2) After initial fluid resuscitation but still requiring norepinephrine to maintain arterial pressure or hyperlactacidemia.

3) Need ongoing analgesia and sedation. 4) Using advanced invasive hemodynamic monitoring techniques.

Exclusion criteria were as follows:

  1. age less than 18 years.
  2. pregnancy.
  3. heart rate less than 55 beats per minute.
  4. acute hepatic failure
  5. brain injury.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Dexmedetomidine
Before dexmedetomidine infusion
Drug: Dexmedetomidine 0.7 Mcg/kg/h
CIF 0.7mcg/kg/h
Other Names:
  • Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perfused vascular density
Time Frame: One hour
Perfused vascular density was calculated by multiplying vessel density by the proportion of perfused vessels
One hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microcirculatory flow index
Time Frame: One hour
Based on the major type of flow in all quadrants were determined with a semi-quantitative methodology
One hour
Total vascular density
Time Frame: One hour
Vascular density was calculated by the number of vessels crossing these lines
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Investigators

  • Study Director: fengmei Guo, MD,PhD, Southeast university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2014

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (ESTIMATE)

October 21, 2014

Study Record Updates

Last Update Posted (ACTUAL)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 10, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014ZDSYLL093.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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