Co-administration of Iloprost and Eptifibatide in Septic Shock Patients
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
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.