Hemodynamic Effects of Dexmedetomidine in Septic Shock

NCT ID: NCT02638545

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-02-28

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.

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.

Conditions

Septic Shock

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Sedation with propofol and remifentanyl will be replaced by a sedation with dexmedetomidine and remifentanyl

Interventions

Dexmedetomidine

Sedation with propofol and remifentanyl will be replaced by a sedation with dexmedetomidine and remifentanyl

Intervention Type: DRUG

Other Intervention Names

Dexdor

Eligibility Criteria

Inclusion Criteria

• septic shock
• need for sedation

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Andrea Morelli

MD, associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Morelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza

Rome, , Italy

Countries

Italy

Other Identifiers

3820

Identifier Type: -

Identifier Source: org_study_id