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Dexmedetomidine on Microcirculation in Septic Shock

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine 0.7 Mcg/kg/h
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Sepsis, Sedation, Microcirculation, Dexmedetomidine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongda Hospital Southeast University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dexmedetomidine

Arm Description

Before dexmedetomidine infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2014
Last Updated
December 10, 2018
Sponsor
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT02270281
Brief Title
Dexmedetomidine on Microcirculation in Septic Shock
Official Title
Dexmedetomidine Improve Microcirculatory Alterations in Initial Resuscitated Septic Shock Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Sepsis, Sedation, Microcirculation, Dexmedetomidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Other
Arm Description
Before dexmedetomidine infusion
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine 0.7 Mcg/kg/h
Other Intervention Name(s)
Dexmedetomidine
Intervention Description
CIF 0.7mcg/kg/h
Primary Outcome Measure Information:
Title
Perfused vascular density
Description
Perfused vascular density was calculated by multiplying vessel density by the proportion of perfused vessels
Time Frame
One hour
Secondary Outcome Measure Information:
Title
Microcirculatory flow index
Description
Based on the major type of flow in all quadrants were determined with a semi-quantitative methodology
Time Frame
One hour
Title
Total vascular density
Description
Vascular density was calculated by the number of vessels crossing these lines
Time Frame
One hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: age less than 18 years. pregnancy. heart rate less than 55 beats per minute. acute hepatic failure brain injury.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fengmei Guo, MD,PhD
Organizational Affiliation
Southeast University
Official's Role
Study Director
Facility Information:
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15343008
Citation
Sakr Y, Dubois MJ, De Backer D, Creteur J, Vincent JL. Persistent microcirculatory alterations are associated with organ failure and death in patients with septic shock. Crit Care Med. 2004 Sep;32(9):1825-31. doi: 10.1097/01.ccm.0000138558.16257.3f.
Results Reference
result
PubMed Identifier
30458880
Citation
Massey MJ, Hou PC, Filbin M, Wang H, Ngo L, Huang DT, Aird WC, Novack V, Trzeciak S, Yealy DM, Kellum JA, Angus DC, Shapiro NI; ProCESS investigators. Microcirculatory perfusion disturbances in septic shock: results from the ProCESS trial. Crit Care. 2018 Nov 20;22(1):308. doi: 10.1186/s13054-018-2240-5.
Results Reference
result
PubMed Identifier
27480413
Citation
Hernandez G, Tapia P, Alegria L, Soto D, Luengo C, Gomez J, Jarufe N, Achurra P, Rebolledo R, Bruhn A, Castro R, Kattan E, Ospina-Tascon G, Bakker J. Effects of dexmedetomidine and esmolol on systemic hemodynamics and exogenous lactate clearance in early experimental septic shock. Crit Care. 2016 Aug 2;20(1):234. doi: 10.1186/s13054-016-1419-x.
Results Reference
result
PubMed Identifier
23963131
Citation
Geloen A, Chapelier K, Cividjian A, Dantony E, Rabilloud M, May CN, Quintin L. Clonidine and dexmedetomidine increase the pressor response to norepinephrine in experimental sepsis: a pilot study. Crit Care Med. 2013 Dec;41(12):e431-8. doi: 10.1097/CCM.0b013e3182986248.
Results Reference
result
PubMed Identifier
30394918
Citation
Morelli A, Sanfilippo F, Arnemann P, Hessler M, Kampmeier TG, D'Egidio A, Orecchioni A, Santonocito C, Frati G, Greco E, Westphal M, Rehberg SW, Ertmer C. The Effect of Propofol and Dexmedetomidine Sedation on Norepinephrine Requirements in Septic Shock Patients: A Crossover Trial. Crit Care Med. 2019 Feb;47(2):e89-e95. doi: 10.1097/CCM.0000000000003520.
Results Reference
result
PubMed Identifier
25313879
Citation
Miranda ML, Balarini MM, Bouskela E. Dexmedetomidine attenuates the microcirculatory derangements evoked by experimental sepsis. Anesthesiology. 2015 Mar;122(3):619-30. doi: 10.1097/ALN.0000000000000491.
Results Reference
result
PubMed Identifier
27111533
Citation
Yeh YC, Wu CY, Cheng YJ, Liu CM, Hsiao JK, Chan WS, Wu ZG, Yu LC, Sun WZ. Effects of Dexmedetomidine on Intestinal Microcirculation and Intestinal Epithelial Barrier in Endotoxemic Rats. Anesthesiology. 2016 Aug;125(2):355-67. doi: 10.1097/ALN.0000000000001135.
Results Reference
result

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Dexmedetomidine on Microcirculation in Septic Shock

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