Placebo Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis

• Conditions: severe sepsis / septic shock; MedDRA version: 14.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2007-004333-42-DE
• Lead Sponsor: Friedrich-Schiller-University of Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-07
• Last Update Posted: 26 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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
11. severely immunocompromised patients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - effect of interventions on 28-day total mortality;Secondary Objective: - effect of interventions on <br>1. organ dysfunctions<br>2. hospital and ICU length of stay / 90-day total mortality<br>3. frequency and duration of mechanical ventilation<br>4. frequency and duration of renal replacement therapy<br>5. frequency and duration of therapy with vasopressors<br>6. safety of the interventions<br>7. 28-day total mortality and secondary objects 1 to 6 in the subgroup of patients, who survived at least 48 hours<br><br>8. rapid eradication of infections by Procalcitonin<br>9. duration, resistance and costs of antibitotic therapy by Procalcitonin ;Primary end point(s): 28-day total mortality;Timepoint(s) of evaluation of this end point: 28 days after randomisation