To demonstrate superiority of selepressin plus standard care versus placebo plus standard care in the number of vasopressor- and mechanical ventilator-free days (with penalty for mortality) in patients with vasopressor-dependent septic shock
ID
Source
Brief title
Condition
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Vasopressor- and mechanical ventilator-free days (P&VFDs) up to Day 30. This
composite endpoint is defined as the number of days (reported to one decimal
place [0.0 to 30.0 days]) from start of treatment with the investigational
medicinal product (IMP) [selepressin or placebo] to 30.0 days thereafter during
which the patient is: 1) alive; 2) free of treatment with intravenous
vasopressors; and 3) free of any invasive mechanical
ventilation.
Secondary outcome
All-cause mortality (defined as the fraction of patients that have died,
regardless of cause) at Day 90
Renal replacement therapy (RRT)-free days up to Day 30 (excluding patients on
RRT for chronic renal failure at time of randomisation)
Intensive care unit (ICU)-free days up to Day 30
Background summary
Selepressin may serve a dual role of providing haemodynamic benefit while
reducing the leakage of intravascular fluid into the extracellular space. It is
believed that these unique characteristics could help address the unmet need in
the treatment of vasopressor-dependent septic shock and provide significant
benefit for the patients.
Study objective
To demonstrate superiority of selepressin plus standard care versus placebo
plus standard care in the number of vasopressor- and mechanical ventilator-free
days (with penalty for mortality) in patients with vasopressor-dependent septic
shock
Study design
This is a double-blind, randomised, placebo-controlled, two-part adaptive
clinical trial. The trial is designed to investigate the efficacy and safety of
multiple dosing regimens of selepressin and to confirm the efficacy and safety
of one dosing regimen in treatment of adult patients with septic shock
requiring vasopressor.
Intervention
The trial is designed to investigate the efficacy and safety of multiple dosing
regimens of selepressin and to confirm the efficacy and safety of one dosing
regimen in treatment of adult patients with septic shock requiring vasopressor.
Study burden and risks
Risk of participating in the trial
Selepressin is an investigational drug and problems or adverse events that are
not known at this time may occur. It is possible that selepressin could cause
reactions or discomfort and there may be risks to patients participating in
this trial. The potential risks associated with the participation in this
research trial will be explained to the subject (or the legally authorised
representative) before the decision to participate or not. The trial staff will
follow the subject*s condition closely from the onset of septic shock and look
for and treat any possible adverse events.
It is not known whether selepressin will harm an unborn baby. Therefore,
pregnant women cannot participate in the trial.
Benefit of participating in the trial
The subject may benefit as a result of his/her participation in this trial.
However, there is no guarantee that the subject will benefit from the
participation in this trial.
The information obtained from this trial may help the trial doctor and other
doctors to better treat patients with septic shock in the future.
Kay Fiskers Plads 11
Copenhagen S 2300
DK
Kay Fiskers Plads 11
Copenhagen S 2300
DK
Listed location countries
Age
Inclusion criteria
1. 18 years of age or older.
2. Proven or suspected infection.
3. Septic shock defined as hypotension (systolic blood pressure less than
90 mmHg OR MAP less than 65 mmHg) requiring vasopressor treatment
(i.e. any dose of norepinephrine / noradrenaline greater than 5 *g/min)
despite adequate fluid resuscitation (at least one litre for hypotension).
4. Informed consent obtained in accordance with local regulations.
Exclusion criteria
1. Not possible to initiate IMP treatment within 12 hours from onset of vasopressor treatment for septic shock.
2. Primary cause of hypotension not due to sepsis (e.g. major trauma including traumatic brain injury, haemorrhage, burns, or congestive heart failure/cardiogenic shock).
3. Previous severe sepsis with ICU admission within this hospital stay.
4. Known/suspected acute mesenteric ischaemia.
5. Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG during this episode of septic shock.
6. Chronic mechanical ventilation for any reason OR severe chronic obstructive pulmonary disease (COPD) requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of COPD) during the preceding 30 days.
7. Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia.
8. Known to be pregnant.
9. Decision to limit full care taken before obtaining informed consent.
10. Use of vasopressin in the past 12 hours prior to start of the IMP infusion or use of terlipressin within 7 days prior to start of the IMP infusion.
11. Prior enrolment in the trial.
12. Prior use of an investigational medicinal product within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or investigational device.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR201400397341-NL |
| ClinicalTrials.gov | NCT02508649 |
| CCMO | NL53983.091.15 |