Prospective randomized clinical multicenter trial about the effect of an adjunctive intravenous treatment with sodium selenite (selenase®T, double-blind) and a procalcitonin guided causal therapy (open) on the survival of patients with severe sepsis and septic shock. - SISPCT

Overview

No summary available.

Registry

who.int

Start Date

March 7, 2008

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Severe sepsis or septic shock
•2\. Beginning of severe sepsis or of septic shock within the last 24 hours
•3\. age \>\= 18 years
•4\. Written informed consent of the patient or his court\-appointed guardian or legal representative
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•1\. Pregnant or nursing women
•2\. women of child bearing potential without using a highly effective method of birth control. This is defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
•3\. Participation in other clinical trials within the last 30 days
•4\. Current participation in any other scientific investigation or any other clinical trial
•5\. Previous participation in this clinical trial
•6\. Selenium intoxication
•7\. Therapy restriction or adjustment (e.g. DNR \- order)
•8\. Bad prognosis due to accompanying disease(s)
•9\. Close relationship to the trial physician (co\-workers, relatives, colleagues)
•10\. presence of infection, where guidelines recommend an antimicrobiological therapy for a longer time