Vasodilatory hypotension in early septic shock MedDRA version: 13.1 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: FE 202158 0.1 mg/ml
Product Code: FE 202158
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 876296-47-8
Current Sponsor code: FE 202158
Concentration unit: mg/ml m
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following inclusion criteria must be met before the subject can enter into the trial: 1. Signed informed consent form by the patient or a legal representative according to local regulations 2. Man or woman 18 years of age or older 3. Proven or suspected infection 4. Vasodilatory hypotension (systolic blood pressure less than 90 mmHg or decrease in systolic blood pressure by at least 40 mmHg for more than one hour) that has not responded to fluid (20 ml/kg of crystalloid or 10 ml/kg of colloid), requiring norepinephrine at a dose of at least 0.1 µg/kg/min, or a minimal dose of 11.5 µg/min (males) and 10.0 µg/min (females) for patients with a body weight above 115 kg (men) or 100 kg (women) for at least 2 hours 5. Signs of tissue hypoperfusion (at least one of the following criteria): Oliguria (=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Any subject meeting one or more of the following exclusion criteria can not be included in the trial: 1. Present or a history (within the last 5 years) of acute coronary syndrome (myocardial infarction or unstable angina). Patients who have been asymptomatic for 6 months after coronary revascularisation are eligible. Known or suspected coronary ischemia. 2. Hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed capillary filling, low cardiac filling pressure, marked systolic or pulse pressure variation or positive leg raising test 3. Known or suspected cardiac failure, e.g. CI < 3 l/min/ m2, left ventricular ejection fraction (LVEF) = 40 %, bilateral pulmonary edema/congestion and cardiomegaly, ScvO2 (superior vena cava) < 64 %, known or suspected coronary ischemia, cold extremities with delayed capillary filling, distended neck veins. 4. Pregnancy or breastfeeding 5. Any cause of hypotension other than early septic shock 6. Use of vasopressin or terlipressin for blood pressure support during the current hospital admission 7. Proven or suspected acute mesenteric ischemia, as judged by the investigator 8. Known episode of septic shock within 1 month prior to randomisation 9. Death anticipated within 24 hours 10. Underlying chronic heart disease, including heart failure NYHA class III or IV 11. Known past or current 2nd and 3rd degree AV-block without a well functioning pacemaker 12. Hyponatremia (serum/plasma sodium <130 mmol/L) 13. Traumatic brain injury (Glasgow Coma Score <8 prior to onset of sepsis) 14. Present hospitalisation with burn injury 15. Symptomatic peripheral vascular disease including Raynaud’s syndrome 16. Previously randomised in this trial 17. Intake of an IMP within the last 3 months (or longer if judged by the Investigator to possibly influence the outcome of the current study) 18. Known participation in another clinical trial 19. Considered by the investigator to be unsuitable to participate in the trial for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish Proof-of-Concept for specific V1a agonism in patients with vasodilatory hypotension in early septic shock (stabilisation of adequate blood pressure) ;Secondary Objective: a) To assess the pharmacokinetics of FE 202158 in patients with vasodilatory hypotension in early septic shock b) To assess the pharmacodynamic effects of FE 202158 with special focus on blood pressure, vascular leakage and inflammatory response. c) To detect early signals suggestive of clinical efficacy of FE 202158 (morbidity and mortality) d) To assess the safety and tolerability of FE 202158 in patients with vasodilatory hypotension in early septic shock ;Primary end point(s): Primary endpoints: Stabilisation of blood pressure a) Proportion of patients maintaining target MAP with no open label NE at 12 hours, 24 hours, 48 hours, 96 hours and Day 7 b) Proportion of patients maintaining target MAP at 12 hours, 24 hours, 48 hours, 96 hours and Day 7 c) Cumulative dose and infusion rates of open label NE (every 12 hours for 3 days, then daily);Timepoint(s) of evaluation of this end point: 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 96 hours and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetics, Pharmacodynamics, Effect on vascular leakage, safety and tolerability, morbidity, mortality;Timepoint(s) of evaluation of this end point: Several - please refer to protocol | — |
Countries
Belgium, Canada, Denmark, United States
Contacts
Public ContactClinical Development Support
Ferring Pharmaceuticals
Outcome results
None listed