Effects of the V1a Agonist FE 202158 in Patients With Septic Shock

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 randomised 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