Severe Sepsis | Angiotensin II Antagonist in Severe Sepsis
Severe Sepsis research study
What is the primary objective of this study?
The investigators propose a clinical study of irbersartan for the early treatment of severe sepsis patients with elevated predicted risk of death between. This study will evaluate whether early administration of the the angiotensin receptor blocker irbersartan provides significant reduction of 28 days mortality and multi organ failure incidence to patients with severe sepsis.
Who is eligible to participate?
Inclusion Criteria: adults within 12 hrs of recognition of severe sepsis, with Acute Physiology and Chronic Health Evaluation (APACHE) II-predicted risk of mortality between 20% and 80% are eligible. Exclusion Criteria:Patients already treated with ACE inhibitors or ARBs will be excluded. Patients admitted in shock conditions (systolic blood pressure lower than 90 mmHg) will be excluded. Patients with severe renal failure (serum creatinine of 2.0 mg/dL or dialysis) will be excluded.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Irbesartan75 mg/per os/for 15 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
irbesartanIrbesartan (total dose of 75 mg) or placebo administered every 24 hrs for 15 days. Moreover, the sepsis management will follow standard international guidelines (Crit Care Med.2008 Jan;36(1):296-327. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock). Duration of treatment: Irbesartan 75 mg daily for 15 days; only one cycle. Follow up will last 90 days both for treatment and control arm. Route of administration : oral by nasogastric tube. Medication permitted and not permitted during the trial: all the therapeutic interventions for sepsis management as indicated by international guidelines are admitted. During the trial are not permitted: ACE inhibitors, ARBs different from Irbersartan, angiotensin I synthesis inhibitors
PlaceboPackaging and labelling for blinding purposes: tablets of placebo looking like the study drug
Start Date: January 2014
Completed Date: January 2017
Phase: Phase 3
Primary Outcome: mortality
Secondary Outcome: Incidence of altered organ function in sepsis patients measured by SOFA score (Sequential Organ Failure Assessment score)
Study sponsors, principal investigator, and references
Principal Investigator: Rosalba Tufano, MD
Lead Sponsor: University of Salerno
Collaborator: Federico II University