Co-administration of Iloprost and Eptifibatide in Septic Shock Patients
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective Evaluating the safety and efficacy of iloprost and eptifibatide co-administration
      compared to placebo as an addition to standard care in septic shock patients.

      Trial rationale Iloprost and eptifibatide combination therapy in septic shock patients is
      expected to deactivate the endothelium and restore vascular integrity, reduce formation of
      microvascular thrombosis and dissolve existing clots in the microcirculation and maintain
      platelet counts, thereby improving platelet-mediated immune function and reducing the risk of
      bleeding. Together this is expected to translate into reduced organ failure and improved
      outcome in patients with septic shock.

      Trial population The trial population is patients >18 years admitted to the ICU with septic
      shock within the last 24h. Eighteen evaluable septic shock patients will be included.

      Trial design This is a single center, randomized (2:1, active:placebo), placebo controlled,
      double-blind investigator-initiated phase IIa trial in patients with septic shock,
      investigating the safety and efficacy of co-administration of Iloprost and Eptifibatide as a
      48h continuous i.v infusion in totally 18 patients.

      All patients will receive standard ICU care including LMWH thrombosis prophylaxis.

      As all patients present at the trial site in an acute, critical condition, scientific
      guardians will co-sign the informed consent form before inclusion. Next-of-kin and the
      patients' general practitioner will co-sign as soon as possible and the patient will provide
      informed consent whenever possible. The active treatment is expected to improve the clinical
      condition of the individual patient and to provide information that may translate into
      improved therapy of future sepsis patients.

      During the study, blood samples will be taken at different time points. Patients will be
      observed and assessed continuously with regards to complications including bleeding. Patients
      will be actively assessed as long as the patient is in the ICU. During the extended follow up
      period at day 30 and 90, contact will be made with the patients to follow up on safety events
      and vital status.

      The trial is conducted in accordance with the protocol and the current regulatory
      requirements and legislation in Denmark.

      Investigational product The active treatment in the trial comprises co-administration of 1
      ng/kg/min Ilomedin® and 0.5 µg/kg/min Integrilin® as 48h continuous i.v infusions. The drugs
      will be purchased and administered according to the product specifications.

      Placebo The placebo in the trial is 0.9% saline as 48h continuous i.v infusion, which will be
      used as placebo for both study drugs. The i.v volume of placebo saline to be administered is
      equal to the administered volume of diluted (in 0.9% saline) active drug.

      Data protection In compliance with the Danish data protection law, the trial will be approved
      by the Danish Data Protection Agency.

      Sponsor of study and financial support This research project is investigator-initiated by the
      trial sponsor and co-investigator Sisse R. Ostrowski and co-investigator Pär I. Johansson in
      collaboration with the principal investigator Morten Bestle.

      It has not received funding from any commercial sponsors.

      Time line Patient recruitment period runs from September 2014 to August 2015. Follow-up data
      on 30-day and 90-day outcome and adverse events will be collected. Initial data analyses will
      be done after completion of 30-day follow-up for all patients. Secondary data analyses will
      be done after completion of 90-day follow-up for all patients.
    


Intervention name(s): Iloprost+eptifibatide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Ilomedin(R); Integrilin(R); 0.9% saline, double dummy
Intervention MeSH terms: Iloprost; Eptifibatide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment