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The Effect of Dexmedetomidine on Microcirculation in Severe Sepsis

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ClinicalTrials.gov Identifier: NCT02109965
Recruitment Status : Terminated
First Posted : April 10, 2014
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Despite early goal-directed maintenance of normal macrocirculation, the reduction of 60-day mortality of patients with severe sepsis and septic shock remained unsatisfied (56.9% to 44.3%). One of the major causes of high mortality is microcirculatory dysfunction. Delayed diagnosis and treatment of microcirculatory dysfunction may cause tissue hypoperfusion and resulted in multiple organ dysfunction and death. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist which exhibits sedative and analgesic effects. Recent studies suggest that dexmedetomidine also has anti-coagulation and anti-inflammatory effects, and it can reduce the mortality of endotoxemic rats and patients with severe sepsis. The investigators will conduct two animal studies and one clinical trial to investigate the effect of dexmedetomidine on microcirculatory dysfunction and organ injury in rat with endotoxemia and patients with severe sepsis and septic shock.

Sixty patients with severe sepsis and septic shock will be enrolled and randomized to control group or dexmedetomidine group. In the control group, the patients will be treated according to the clinical practice guideline. If sedation is required, non-dexmedetomidine sedative agents will be used. In the dexmedetomidine group, the patients will be treated according to the clinical practice guideline, and they will also receive continuous infusion of dexmedetomidine (infusion rate ranged from 0.1 to 0.7 mcg/kg/h) for 24 hours as needed. The sublingual microcirculation, serum level of Endocan, NGAL(Neutrophil Gelatinase-Associated Lipocalin), and BNP(B-type natriuretic peptide) will be examined at preset time points up to 24 hours. The vital signs, hemodynamic parameters, and survival of 28-day and 90-day will be recorded and analyzed.


Condition or disease Intervention/treatment Phase
Severe Sepsis Drug: Dexmedetomidine Drug: Midazolam Drug: Propofol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Dexmedetomidine on the Microcirculation in Patients With Severe Sepsis and Septic Shock
Study Start Date : July 2014
Actual Primary Completion Date : February 24, 2016
Actual Study Completion Date : February 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Active Comparator: Control
Use midazolam or propofol for sedation
Drug: Midazolam
CIF Goal of sedation: Richmonad agitation-sedation scale 0 to -2
Other Name: Dormicium

Drug: Propofol
CIF Goal of sedation: Richmonad agitation-sedation scale 0 to -2
Other Name: Propofol-Lipuro

Experimental: Dexmedetomidine
Use dexmedetomidine for sedation
Drug: Dexmedetomidine
Continue infusion (CIF) 0.1 - 0.7 mcg/kg/h Goal of sedation: Richmonad agitation-sedation scale 0 to -2
Other Name: Precedex




Primary Outcome Measures :
  1. Changes of total small vessel density and perfused small vessel density [ Time Frame: 6h ]

Secondary Outcome Measures :
  1. Changes of total small vessel density and perfused small vessel density [ Time Frame: 24h ]
  2. Change of microvascular flow index [ Time Frame: 6h and 24h ]

Other Outcome Measures:
  1. Endocan level [ Time Frame: 24h ]
  2. Hemodynamic variables [ Time Frame: 6h and 24h ]
    Use EV1000 clinical platform MAP HR Cardiac index Stroke volume index Systemic vascular resistance index

  3. NGAL level [ Time Frame: 6h and 24h ]
    Neutrophil Gelatinase-Associated Lipocalin

  4. BNP level [ Time Frame: 24h ]
    B-type natriuretic peptide)



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICU patients who require sedation
  • Patients who have diagnosis of severe sepsis / septic shock
  • meet 2 or more of the 4 SIRS criteria
  • with one organ dysfunction according the definition of Surviving Sepsis Campaign

Exclusion Criteria:

  • less than 20 y/o
  • refractory bradycardia (heart rate slower than 60 bpm despite of adequate treatment)
  • 2nd and 3rd degree of AV-block
  • the onset of severe sepsis/septic shock is more than 24h before enrollment
  • APACHE II > 30 at enrollment
  • Severe liver cirrhosis (Child B or C)
  • New onset of myocardial infarction within 30 days or heart failure (NYHA 4)
  • attend other trial in ICU within one month
  • patient who is pregnant
  • receive organ transplantation within one year
  • expected survival is less than 30 days by attending physician
  • receive cardiopulmonary resuscitation within 4 weeks
  • patients who have signed consent of refusal of cardiopulmonary resuscitation and invasive therapy
  • have allergic history to dexmedetomidine
  • receive renal replacement therapy within 24 hours before enrollment
  • patient with HIV infection
  • non-native speaker
  • other factors not eligible for enrollment concerned by attending physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109965


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Director: Yu-Chang Yeh, MD, PhD National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02109965    
Other Study ID Numbers: 201311031MINB
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Midazolam
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators