Skip to main content
OpenTrials
Completed

NCT Number: NCT02270281

Dexmedetomidine on Microcirculation in Septic Shock

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

  • After initial fluid resuscitation but still requiring norepinephrine to maintain arterial pressure or hyperlactacidemia.
  • Need ongoing analgesia and sedation. 4) Using advanced invasive hemodynamic monitoring techniques.

Exclusion criteria

were as follows:

  • age less than 18 years.
  • pregnancy.
  • heart rate less than 55 beats per minute.
  • acute hepatic failure
  • brain injury.

Treatment and study plan

Dexmedetomidine 0.7 Mcg/kg/h

Drug

CIF 0.7mcg/kg/h

Other names: Dexmedetomidine

Primary outcomes

  1. Perfused vascular density

    Time frame: One hour

    Perfused vascular density was calculated by multiplying vessel density by the proportion of perfused vessels

Secondary outcomes

  1. Microcirculatory flow index

    Time frame: One hour

    Based on the major type of flow in all quadrants were determined with a semi-quantitative methodology

  2. Total vascular density

    Time frame: One hour

    Vascular density was calculated by the number of vessels crossing these lines

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Dexmedetomidine Improve Microcirculatory Alterations in Initial Resuscitated Septic Shock Patients

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Oct 21, 2014
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.