Viewing Study NCT03208257


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Study NCT ID: NCT03208257
Status: UNKNOWN
Last Update Posted: 2019-02-26
First Post: 2017-07-02
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Esmolol to Control Adrenergic Storm in Septic Shock- ROLL-IN 2
Sponsor: Samuel Brown
Organization:

Study Overview

Official Title: Esmolol to Control Adrenergic Storm in Septic Shock- ROLL-IN 2
Status: UNKNOWN
Status Verified Date: 2019-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ECASSS-R2
Brief Summary: Septic shock is a common syndrome caused by the body's response to an infection. Septic shock is responsible for 10% of all ICU admissions and 30% of ICU deaths. Use of "beta blocker" medications may improve outcomes after septic shock. This pilot study evaluates protocols to infuse the beta blocker esmolol in patients with septic shock.
Detailed Description: This is a prospective, single arm, feasibility study of esmolol infusion in septic shock. The objective is to evaluate the feasibility, adequacy, and efficiency of study protocols for a subsequent ECASSS study. This study (ECASSS-R2) extends observations made in an initial pilot, ECASSS-R.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: