Dexmedetomidine on Microcirculation in Septic Shock

NCT02270281 | Completed Phase 4 DMC

• 1 other identifier: 2014ZDSYLL093.0
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

Sepsis; Sedation; Microcirculation; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Perfused vascular density

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

  One hour

Secondary Outcomes (2)

• Microcirculatory flow index

  One hour

• Total vascular density

  One hour

Study Arms (1)

Dexmedetomidine

OTHER

Before dexmedetomidine infusion

Drug: Dexmedetomidine 0.7 Mcg/kg/h

Interventions

Dexmedetomidine 0.7 Mcg/kg/h DRUG

CIF 0.7mcg/kg/h

Also known as: Dexmedetomidine

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (8)

• 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.

  PMID: 15343008 RESULT

• 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.

  PMID: 30458880 RESULT

• 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.

  PMID: 27480413 RESULT

• 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.

  PMID: 23963131 RESULT

• 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.

  PMID: 30394918 RESULT

• 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.

  PMID: 25313879 RESULT

• 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.

  PMID: 27111533 RESULT

• Xu J, Wang Y, Shu C, Chang W, Guo F. Dexmedetomidine Improves Microcirculatory Alterations in Patients With Initial Resuscitated Septic Shock. J Intensive Care Med. 2025 Feb;40(2):137-144. doi: 10.1177/08850666241267860. Epub 2024 Aug 28.

  PMID: 39193773 DERIVED

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• fengmei Guo, MD,PhD

  Southeast University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 21, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

CN (1)