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

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 |
- norepinephrine dose [ Time Frame: 4 hours ]
- cardiac output [ Time Frame: 4 hours ]
- mean arterial pressure [ Time Frame: 4 hours ]
- heart rate [ Time Frame: 4 hours ]

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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 |
Inclusion Criteria:
- septic shock
- need for sedation
Exclusion Criteria:
-

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
Italy | |
Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza | |
Rome, Italy, 00161 |
Principal Investigator: | Andrea Morelli, MD | University of Roma La Sapienza |
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 |
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 |