Angiotensin II Antagonist in Severe Sepsis

NCT01992796 | Unknown Phase 3 DMC

• 1 other identifier: FARM97AJNN
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Sepsis

Keywords

irbesartan, angiotensin, sepsis

Outcome Measures

Primary Outcomes (1)

• mortality

  28 days

Secondary Outcomes (1)

• Incidence of altered organ function in sepsis patients measured by SOFA score (Sequential Organ Failure Assessment score)

  28 day

Other Outcomes (1)

• Incidence of renal failure

  28 days

Study Arms (2)

irbesartan

EXPERIMENTAL

Irbesartan (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

Drug: Irbesartan

Placebo

PLACEBO COMPARATOR

Packaging and labelling for blinding purposes: tablets of placebo looking like the study drug

Interventions

Irbesartan DRUG

75 mg/per os/for 15 days

Also known as: Candesartan., Telmisartan., Olmesartan., Lortaan, Losaprex, Neolotan, Tevetenz, Rixil, Tareg, Valpression, Aprovel, Karvea.

irbesartan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Salerno: lead
• Federico II University: collaborator

Study Sites (1)

Università di Salerno

Salerno, Italy

Location

MeSH Terms

Conditions

Sepsis

Interventions

Irbesartan; candesartan; Telmisartan; olmesartan; Valsartan

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Rosalba Tufano, MD

  Federico II University

  STUDY DIRECTOR

Central Study Contacts

Rosalba Tufano, MD

CONTACT

rtufano@unina.it

Ornella Piazza, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reasercher

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

IT (1)