CompletedPhase 2

Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock

Belgium, Denmark31 participantsStarted 2012-06

Plain-language summary

The purpose of this trial is to investigate the potential of FE 202158 as a treatment which can stabilize blood pressure for treatment of patients in early septic shock.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed informed consent form by the patient or a legal representative according to local regulations' * Man or women 18 years of age or older * Body weight below 115 kg for male patients and 100 kg for female patients * Proven or suspected infection * Septic shock, i.e. vasodilatory hypotension requiring vasopressor support * Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from informed consent to one week after the end of infusion of study medication Exclusion Criteria: * Present or a history within the last 6 months of symptoms of acute coronary syndrome (myocardial infarction or unstable angina) * Known or suspected endocarditis * 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 * Known or suspected infection with (HIV)-1, HIV-2, hepatitis B, or hepatitis C * Pregnancy or breastfeeding * Any cause of hypotension other than early septic shock * Use of vasopressin or terlipressin within 7 days prior to start of IMP infusion * Proven or suspected acute mesenteric ischemia, as judged by the investigator * Known episode of septic shock within 1 month prior to screening * Death anticipated within 24 hours, or due to the underlying disease within 3 months * Known past or current 2nd and 3rd degree AV-block without a well …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1

Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine