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Clinical Trials/EUCTR2017-002138-22-IT
EUCTR2017-002138-22-IT
Active, not recruiting
Phase 1

Phase IV, multicenter, prospective, randomized, open-label, controlled study on Landiolol in patients with septic shock resident in an Intensive Care Unit (LANDI-SEP) - LANDI-SEP

AOP ORPHAN PHARMACEUTICALS AG0 sites200 target enrollmentJanuary 31, 2020
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DrugsLANDIOBLOC - 300 MG POLVERE PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
AOP ORPHAN PHARMACEUTICALS AG
Enrollment
200
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 31, 2020
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\) 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
  • •2\) Tachycardia and/or tachyarrhythmia with heart rate \=95 beats/min
  • •3\) Norepinephrine infusion rate \=0\.2µg/kg/min at the time of study inclusion
  • •4\) Patients must have undergone a hemodynamic optimization period of at least 24 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
  • •5\) Age \=18 years

Exclusion Criteria

  • •1\.Any form of compensatory tachycardia
  • •2\.ß\-blocker treatment within 7 days prior randomization
  • •3\.Sick Sinus syndrome, or 2nd or 3rd degree AV block
  • •4\.Patients with any form of cardiac pacing
  • •5\.A known serious cardiovascular condition such as ischemic stroke or transient ischemic attack within last 6 months, or preexisting heart failure New York Heart Association Class III or 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: 23.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
EUCTR2017-002138-22-PLAOP Orphan Pharmaceuticals AG200
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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]
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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