Hemodynamic Effects of Dexmedetomidine in Septic Shock

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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:

-

Contacts and Locations

Locations

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

• Principal Investigator: Andrea Morelli, MD; University of Roma La Sapienza

More Information

• 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
• 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:

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