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Hemodynamic Effects of Dexmedetomidine in Septic Shock

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ClinicalTrials.gov Identifier: NCT02638545
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Andrea Morelli, University of Roma La Sapienza

Brief Summary:
The current treatment regimen of patients with septic shock requires a sufficient hemodynamic support aiming to preserve tissue oxygen requirements and perfusion. Therefore, aggressive fluid challenge and vasopressor agents play a pivotal role. To increase total peripheral resistance and preserve organ perfusion, a continuous infusion of catecholamines is often needed. Because sepsis is usually associated with adrenergic receptor and post-receptor abnormalities, the efficacy of such treatment regimens often gradually decreases over time, thereby complicating hemodynamic support. Experimental evidence suggest that α-2 agonists increase pressor responsiveness following lipopolysaccharide administration. This study will assess the effects of the sedation with dexmedetomidine (α-2 agonist) on norepinephrine requirements in patients with septic shock.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Dexmedetomidine Phase 3

Detailed Description:

The present study was designed as a prospective study. All patients enrolled in the study will require norepinephrine to maintain MAP between 65 and 75 mmHg despite adequate volume resuscitation and will be sedated according to istitutional guidelines with propofol and remifentanyl. After 8 h had elapsed during stable hemodynamic conditions, an initial set of measurements will be obtained during the sedation with propofol and remifentanyl. This set of measurements will be considered as baseline. In the patients in which conventional sedation will be replaced by dexmedetomidine and remifentanyl, a second set of measurements will be obtained after 4 h had elapsed during stable conditions. A final set of mesurements will be obtained after another 8-h period in stable conditions after switcheing back again to propofol and remifentanyl, .

During the observational period the dosage rate of norepinephrine will be adjusted to maintain the same threshold MAP of 65-75 mmHg All other medications were held constant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dexmedetomidine on Pressor Response to Norepinephrine in Patients With Septic Shock
Actual Study Start Date : September 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: dexmedetomidine Drug: Dexmedetomidine
Sedation with propofol and remifentanyl will be replaced by a sedation with dexmedetomidine and remifentanyl
Other Name: Dexdor




Primary Outcome Measures :
  1. norepinephrine dose [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. cardiac output [ Time Frame: 4 hours ]
  2. mean arterial pressure [ Time Frame: 4 hours ]
  3. heart rate [ Time Frame: 4 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • septic shock
  • need for sedation

Exclusion Criteria:

-


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): NCT02638545


Locations
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Italy
Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Andrea Morelli, MD University of Roma La Sapienza
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Responsible Party: Andrea Morelli, MD, associate professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02638545    
Other Study ID Numbers: 3820
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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