EUCTR2017-002138-22-PL
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
ConditionsAdult patients in ICU with septic shock who remain tachycardic (HR =95 bpm) and require vasopressor therapy to maintain a Mean arterial pressure (MAP) of =65 mmHg after a hemodynamic optimization period (at least 12 hours and up to 36 hours).MedDRA version: 20.0Level: PTClassification code 10043071Term: TachycardiaSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 23.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Adult patients in ICU with septic shock who remain tachycardic (HR =95 bpm) and require vasopressor therapy to maintain a Mean arterial pressure (MAP) of =65 mmHg after a hemodynamic optimization period (at least 12 hours and up to 36 hours).
- Sponsor
- AOP Orphan Pharmaceuticals AG
- 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
Similar Trials
Active, not recruiting
Phase 1
Study the effect of Landiolol on elevated heart rate by septic shock patientsAdult patients in ICU with septic shock who remain tachycardic (HR =95 bpm) and require vasopressor therapy to maintain a Mean arterial pressure (MAP) of =65 mmHg after a hemodynamic optimization period (at least 12 hours and up to 36 hours).MedDRA version: 20.0Level: PTClassification code 10043071Term: TachycardiaSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2017-002138-22-EEAOP Orphan Pharmaceuticals AG200
Active, not recruiting
Phase 1
andiolol in patients with septic shock.EUCTR2017-002138-22-ITAOP ORPHAN PHARMACEUTICALS AG200
Active, not recruiting
Phase 1
Study the effect of Landiolol on elevated heart rate by septic shock patientsEUCTR2017-002138-22-ATAOP Orphan Pharmaceuticals GmbH200
Active, not recruiting
Phase 1
Study the effect of Landiolol on elevated heart rate by septic shock patientsAdult patients in ICU with septic shock who remain tachycardic (HR =95 bpm) and require vasopressor therapy to maintain a Mean arterial pressure (MAP) of =65 mmHg after a hemodynamic optimization period (at least 12 hours and up to 36 hours).MedDRA version: 20.0Level: PTClassification code 10043071Term: TachycardiaSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2017-002138-22-CZAOP Orphan Pharmaceuticals AG200
Active, not recruiting
Phase 1
Study the effect of Landiolol on elevated heart rate by septic shock patientsAdult patients in ICU with septic shock who remain tachycardic (HR =95 bpm) and require vasopressor therapy to maintain a Mean arterial pressure (MAP) of =65 mmHg after a hemodynamic optimization period (at least 12 hours and up to 36 hours).MedDRA version: 20.0Level: PTClassification code 10043071Term: TachycardiaSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2017-002138-22-SIAOP Orphan Pharmaceuticals AG200