A study investigating a new treatment for patients with early septic shock
Phase 1
- Conditions
- Hypotension in early septic shockMedDRA version: 15.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-001254-26-BE
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
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
- Primary Outcome Measures
Name Time Method Main Objective: Show that the onset of action allows for FE 202158 to be used as primary vasopressor<br>treatment in patients with vasodilatory hypotension in early septic shock.;Secondary Objective: To assess pharmacodynamics, safety, tolerability and optimal dosing regimen.;Primary end point(s): Stabilisation of blood pressure;Timepoint(s) of evaluation of this end point: Continous assessment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Pharmacokinetics, pharmacodynamics, safety, tolerability, subjective assessments by investigator, morbidity and mortality;Timepoint(s) of evaluation of this end point: Continuous assessment