Clinical trial NCT01612676: Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock
Official title: An Open Label Feasibility Trial Investigating FE 202158 as Potential Primary Vasopressor Treatment in Patients With Vasodilatory Hypotension in Early Septic Shock.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Septic Shock
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-06-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 functioning pacemaker
* Brain injury within current hospitalisation
* Present hospitalisation with burn injury
* Symptomatic peripheral vascular disease including Raynaud's syndrome
* Previously included in this trial
* Intake of an Investigational Medicinal Product (IMP) 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 interventional clinical trial
* Considered by the investigator to be unsuitable to participate in the trial for any other reason

Primary outcomes:
measure: Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine
timeFrame: Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
measure: Cumulative Dose of FE 202158
timeFrame: Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
measure: Infusion Rate of FE 202158
timeFrame: Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
measure: Cumulative Dose of Norepinephrine
timeFrame: Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
measure: Infusion Rate of Norepinephrine
timeFrame: Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
measure: Time to Septic Shock Resolution
timeFrame: Day 1 up to Day 28
Secondary outcomes:
measure: Urinary Output
timeFrame: Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
measure: Fluid Balance
timeFrame: Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
measure: Summary of Investigator Reported Outcomes
timeFrame: Day 1 up to Day 2
measure: Morbidity Assessment
timeFrame: Day 1 up to Day 28
measure: Graded Morbidity
timeFrame: Day 1 up to Day 28
measure: Mortality
timeFrame: Day 1 up to Day 28
measure: Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram
timeFrame: Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital Free University of Brussels
city: Brussels
country: Belgium
facility: Saint-Luc University Hospital
city: Brussels
country: Belgium
facility: University Hospital Brussels
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: