A study investigating a new treatment for patients with early septic shock

• Conditions: Hypotension in early septic shock; MedDRA version: 14.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001254-26-DK
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-31
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients of both sexes, at least 18 years of age, in early Septic shock, i.e. vasodilatory hypotension (systolic blood pressure less than 90 mmHg that has not responded to fluid requiring < 0.6 µg/kg/min norepinephrine vasopressor support
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Male patients weighing >115 kg and female patients weighing >100 kg, brain injury within current hospitalisation, or anticipated death within 24 hours, or due to underlying disease within 3 months, are not eligible.

Study & Design

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