Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03013322
Status:
COMPLETED
Last Update Posted:
2018-01-29
First Post:
2017-01-01
Brief Title:
Anticholium Per Se
Sponsor:
University Hospital Heidelberg
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Anticholium Per Se a Randomized Double-blind Placebo-controlled Monocentric Trial on the Adjunctive Use of Physostigmine Salicylate Anticholium in Perioperative Sepsis and Septic Shock
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
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:
None
Brief Summary:
Anticholium per Se is a randomized double-blind placebo-controlled monocentric trial to assess whether the CAP can be transferred from bench to bedside In this pilot study 20 patients with perioperative sepsis and septic shock as a result of intra-abdominal infection are enrolled According to randomization participants are treated with physostigmine salicylate verum group or 09 sodium chloride placebo group for up to 5 days The mean Sequential Organ Failure Assessment SOFA score during treatment and subsequent intensive care of up to 14 days is used as surrogate outcome primary endpoint Secondary outcome measures include 30- and 90-day mortality An embedded pharmacokinetics and pharmacodynamics study investigates plasma concentrations of physostigmine and its metabolite eseroline Further analyses will contribute to the understanding of the role of various cytokines in the pathophysiology of human sepsis A computer-generated list is used for blocked randomization
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None