Dexmedetomidine on Microcirculation in Septic Shock

NCT ID: NCT02270281

Last Updated: 2018-12-12

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Septic Shock

Keywords

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Sepsis Sedation Microcirculation Dexmedetomidine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine

Before dexmedetomidine infusion

Group Type OTHER

Dexmedetomidine 0.7 Mcg/kg/h

Intervention Type DRUG

CIF 0.7mcg/kg/h

Interventions

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Dexmedetomidine 0.7 Mcg/kg/h

CIF 0.7mcg/kg/h

Intervention Type DRUG

Other Intervention Names

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Dexmedetomidine

Eligibility Criteria

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Inclusion Criteria

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

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

18 Years

Maximum Eligible Age

100 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

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fengmei Guo, MD,PhD

Role: STUDY_DIRECTOR

Southeast University

Locations

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Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 15343008 (View on PubMed)

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.

Reference Type RESULT
PMID: 30458880 (View on PubMed)

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.

Reference Type RESULT
PMID: 27480413 (View on PubMed)

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.

Reference Type RESULT
PMID: 23963131 (View on PubMed)

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.

Reference Type RESULT
PMID: 30394918 (View on PubMed)

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.

Reference Type RESULT
PMID: 25313879 (View on PubMed)

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.

Reference Type RESULT
PMID: 27111533 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39193773 (View on PubMed)

Other Identifiers

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2014ZDSYLL093.0

Identifier Type: -

Identifier Source: org_study_id