Effects of the V1a Agonist FE 202158 in Patients With Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Intervention: FE 202158 1.25; FE 202158 2.5; FE 202158 3.75; Placebo
Intervention description: FE 202158 at dose 1.25 ng/kg/min infused.; FE 202158 at dose 2.5 ng/kg/min infused.; FE 202158 at dose 3.75 ng/kg/min infused.; Isotonic saline infused.
Intervention MeSH terms: Vasopressins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: V1a agonist

Summary:

      The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE
      202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood
      vessel) leakage. FE 202158 had previously been tested in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent form by the patient or a legal representative according to
             local regulations

          -  Man or woman 18 years of age or older

          -  Proven or suspected infection

          -  Low blood pressure

          -  Signs of decreased circulation in the tissues

          -  Willing to use an adequate barrier method or hormonal method of contraception, if not
             abstinent, from the day of informed consent to one week after the end of infusion of
             study medication.

        Exclusion Criteria:

          -  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.

          -  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.

          -  Known or suspected cardiac failure

          -  Pregnancy or breastfeeding

          -  Any cause of hypotension other than early septic shock

          -  Use of vasopressin or terlipressin for blood pressure support during the current
             hospital admission

          -  Proven or suspected acute mesenteric ischemia, as judged by the investigator

          -  Known episode of septic shock within 1 month prior to randomisation

          -  Underlying chronic heart disease

          -  Traumatic brain injury

          -  Present hospitalisation with burn injury

          -  Symptomatic peripheral vascular disease including Raynaud's syndrome

          -  Previously randomized in this trial

          -  Intake of an investigational drug within the last 3 months (or longer if judged by the
             Investigator to possibly influence the outcome of the current study)

          -  Known participation in another clinical trial

          -  Considered by the investigator to be unsuitable to participate in the trial for any
             other reason