Study the effect of Landiolol on elevated heart rate by septic shock patients

Phase 1

• 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).; MedDRA version: 20.0Level: PTClassification code 10043071Term: TachycardiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 23.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002138-22-AT
• Lead Sponsor: AOP Orphan Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-08
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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
11. Patients for whom a Do Not Resuscitate” (DNR) exists
12. Known sensitivity to any component of the study medication (e.g. Landiolol, mannitol)
13. Participation in a clinical drug trial within 30 days prior randomization or prior participation in the LANDI-SEP trial
14. Any condition that, in the Investigator’s opinion, makes the subject unsuitable for study participation (to be documented)
15. Pregnant or breast feeding patients
16. Untreated Pheochromocytoma
17. Anticipated to be in need of beta-blocker therapy prior to vasopressor discontinuation due to their prior medication/ medical history (Investigator ´s opinion)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified