EUCTR2017-002138-22-AT
Active, not recruiting
Phase 1
Phase IV, multicenter, prospective, randomized, open-label, controlled study on Landiolol in patients with septic shock resident in ICUs - LANDI-SEP
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AOP Orphan Pharmaceuticals GmbH
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Informed consent (signed informed consent by the patient or a legal representative or other country\-specific documentation, as required)
- •2\) Age \=18 years
- •3\) Confirmed septic shock: a. Confirmed or suspected infection b. Acute increase of \=2 points on SOFA Score c. Need for continuous vasopressor therapy to maintain a mean arterial pressure (MAP) of \>65 mmHg despite adequate fluid resuscitation d. Blood lactate \>2mmol/L (18mg/dl) Presence of blood lactate \>2mmol/L (18mg/dl) and increase of \=2 points on SOFA Score are only necessary for the diagnosis of septic shock but not at time of study inclusion
- •4\) Tachycardia and/or tachyarrhythmia with heart rate \=95 beats/min
- •5\) Norepinephrine infusion (any dose) at the time of study inclusion
- •6\) Patients must have undergone a haemodynamic optimization period of at least 12 hours but a maximum of 36 hours, during which period they received continuous vasopressor treatment and standard treatment for septic shock according to the SSCG 2016 guidelines
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
Exclusion Criteria
- •1\. Any form of compensatory tachycardia
- •2\. ß\-blocker treatment after septic shock diagnosis
- •3\. Sick Sinus syndrome
- •4\. Severe atrioventricular (AV) nodal conductance disorders (without pacemaker); 2nd or 3rd degree AV block
- •5\. A known serious cardiovascular condition such as ischemic stroke or transient ischaemic attack within last 6 months, or preexisting heart failure New York Heart Association Class IV
- •6\. Cardiogenic shock
- •7\. MAP \<65 mmHg
- •8\. Known pulmonary hypertension
- •9\. Known terminal illness other than septic shock with expected patient’s survival \<28 days
- •10\. Known presence of an advanced condition to withhold life\-sustaining treatment
Outcomes
Primary Outcomes
Not specified
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