Sepsis is a common, expensive, frequently fatal and highly complex inflammatory syndrome
wherein multiple cellular and humoral pathways are involved. Since it's a multifactorial
syndrome merely blocking one of the various inflammatory pathways may not suffice to provide
effective treatment and this may partly explain why most of the adjunctive therapies
developed for severe sepsis have yielded disappointing results in rigorous clinical trials.
Statins have varied pleiotropic effects on the inflammatory mediators and there addition to
the current adjuvant therapies in septic shock may help in reduction of mortality. The
present trial aims to study survival benefit and changes in bio-marker levels in septic
shock.
Adult patients (>=18 years) in septic shock and admitted to ICU will be included in the
study. Patients will be randomized as per computer generated random number into the Drug
(Atorvastatin, 40 mg) or matched placebo group. Drug or placebo will be given to selected
patient via nasogastric tube for 7 days. Bio markers (Il-6, TNF-alpha) estimated during the
trial week (Days 1, 4, and 7). All clinical and study personnel and patients remained blinded
to the study group assignment throughout the trial.
Phase:
N/A
Details
Lead Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences