Evaluation of the effect of the drugs that are antagonists of angiotensin II receptors in sepsis

Phase 1

• Conditions: SEPSIS; MedDRA version: 16.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2012-001100-38-IT
• Lead Sponsor: DIPART. DI NEUROSCIENZE, SCIENZE RIPRODUTTIVE E ODONTOSTOMATOLOGICHE DELL’UNIVERSITà DEGLI STUDI DI NAPOLI FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-15
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients with severe sepsis, hospitalised in the Intensive Care Unit, but able to give the informed consent; Female and Male; Age between 18 and 75 years old; sepsis evaluated wth the publications of the American College of Chest Physician/Society of Critical Care Medicine; multiple organ failure measured by SOFA (Sequential Organ Failure Assessment) score
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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Pregnancy; nursing; pre-existen renal damage (severe renal failure or creatinine value of 2,0 mg/dL or dialysis); patient in treatment with ACE inhibitors or ARBs; shock conditions (systolic blood pressure lower than 90 mmHg): patients inserted, in the previous 12 weeks, in another clinical trial that uses another farmaceutical product; known allergies to ARBs

Study & Design

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