NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Subjects with Sepsis Induced Cardiovascular and Respiratory Failure
Date of first enrollment	10/06/2008
Target sample size	2500
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : TAK-242 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Injection

Outcome(s)

Primary Outcome	28-day all-cause mortality
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Main Inclusion Criteria 1. Subject is aged 18 years or older, with bacterial or infection for which he/she is receiving parenteral antimicrobial therapy. 2. Subject has septic shock diagnosed and developed respiratory failure within 36 hours prior to study drug administration, and meets at least 3 of the 4 SIRS criteria. Main Exclusion Criteria 1. Subject is known to be immunocompromised, and is currently receiving immunosuppressive therapy or a cancer related chemotherapeutic agent. 2. Prior to the onset of sepsis, the subject would not otherwise have been expected to survive 28 days or to complete a functional recovery due to a pre-existing unstable medical condition. 3. Subject has acute third degree burns involving more than 30% of body surface area. 4. Subject, family, or physician is not committed to full aggressive management. 5. Subject has known hypersensitivity to sulphonamides, or is allergic to eggs, egg products or soybeans. 6. Subject has a documented history of chronic heart failure as defined by NYHA functional classification III or IV. 7. Subject has severe end stage chronic respiratory failure or chronic end stage hepatic failure.
Exclude criteria