NCT02638545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

December 18, 2015

Last Update Submit

February 6, 2017

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

  • norepinephrine dose

    4 hours

Secondary Outcomes (3)

  • cardiac output

    4 hours

  • mean arterial pressure

    4 hours

  • heart rate

    4 hours

Study Arms (1)

dexmedetomidine

EXPERIMENTAL
Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

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

Also known as: Dexdor
dexmedetomidine

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • septic shock
  • need for sedation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rome, 00161, Italy

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Andrea Morelli, MD

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, associate professor

Study Record Dates

First Submitted

December 18, 2015

First Posted

December 23, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

February 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)