Hemodynamic Effects of Dexmedetomidine in Septic Shock

Septic Shock Clinical Trial

Official title:

Effects of Dexmedetomidine on Pressor Response to Norepinephrine in Patients With Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638545
• Other study ID #: 3820
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2015
• Last updated: February 6, 2017
• Start date: September 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• septic shock

• need for sedation

Exclusion Criteria:

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Dexmedetomidine
Sedation with propofol and remifentanyl will be replaced by a sedation with dexmedetomidine and remifentanyl

Locations

Country	Name	City	State
Italy	Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	norepinephrine dose		4 hours
Secondary	cardiac output		4 hours
Secondary	mean arterial pressure		4 hours
Secondary	heart rate		4 hours