Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock
20 lutego 2017 zaktualizowane przez: Ferring Pharmaceuticals
An Open Label Feasibility Trial Investigating FE 202158 as Potential Primary Vasopressor Treatment in Patients With Vasodilatory Hypotension in Early Septic Shock.
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.
Przegląd badań
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
31
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Drug
FE 202158
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine
Ramy czasowe: 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.
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Mean arterial pressure (MAP) was measured intra-arterially on a continuous basis.
Success percentage of patients maintaining target/adequate MAP (>60 mmHg) without norepinephrine is presented.
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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.
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Cumulative Dose of FE 202158
Ramy czasowe: 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.
|
Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7.
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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.
|
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Infusion Rate of FE 202158
Ramy czasowe: 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.
|
Infusion rate of FE 202158 was presented from Day 1 up to Day 7.
|
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.
|
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Cumulative Dose of Norepinephrine
Ramy czasowe: 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.
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Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support.
Cumulative dose of norepinephrine was calculated from Day 1 up to Day 7.
|
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.
|
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Infusion Rate of Norepinephrine
Ramy czasowe: 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.
|
Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support.
Infusion rates and all changes in infusion rates of norepinephrine were recorded continuously during the 7 day maximum treatment period.
|
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.
|
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Time to Septic Shock Resolution
Ramy czasowe: Day 1 up to Day 28
|
The Kaplan-Meyer estimation of time to out of septic shock was estimated where time to (first) septic shock resolution was defined as time of end of infusion regimen. Intermittent off treatment periods were regarded as part of the shock duration. Time to all but one patient out of septic shock is presented. |
Day 1 up to Day 28
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Urinary Output
Ramy czasowe: 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.
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The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit.
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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.
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Fluid Balance
Ramy czasowe: 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.
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The fluid balance (accumulated input/output) was recorded in 24-hour collecting periods when the patient was in the intensive care unit and during the infusion of FE 202158.
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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.
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Summary of Investigator Reported Outcomes
Ramy czasowe: Day 1 up to Day 2
|
Investigator reported outcome on FE 202158 performance.
Answers were graded on a visual analogue scale (VAS) from 0 to 10, 0 being the worst and 10 being the best outcome.
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Day 1 up to Day 2
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Morbidity Assessment
Ramy czasowe: Day 1 up to Day 28
|
Percentage of all the "Days alive and out/free of" intensive care unit, hospital, dialysis, or ventilation within Day 28 were summarized.
Patients dying before or at Day 28 were counted as zero.
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Day 1 up to Day 28
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Graded Morbidity
Ramy czasowe: Day 1 up to Day 28
|
Collection of data on graded morbidity was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.
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Day 1 up to Day 28
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Mortality
Ramy czasowe: Day 1 up to Day 28
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Collection of data on mortality was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.
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Day 1 up to Day 28
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Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram
Ramy czasowe: Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion
|
Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters).
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Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion
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Współpracownicy i badacze
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 czerwca 2012
Zakończenie podstawowe (Rzeczywisty)
1 listopada 2013
Ukończenie studiów (Rzeczywisty)
1 listopada 2013
Daty rejestracji na studia
Pierwszy przesłany
11 maja 2012
Pierwszy przesłany, który spełnia kryteria kontroli jakości
5 czerwca 2012
Pierwszy wysłany (Oszacować)
6 czerwca 2012
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
23 marca 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
20 lutego 2017
Ostatnia weryfikacja
1 lutego 2017
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 000025
- 2012-001254-26 (Numer EudraCT)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .