andiolol in patients with septic shock.

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 24 hours and up to 36 hours).; MedDRA version: 20.0 Level: PT Classification code 10043071 Term: Tachycardia System Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002138-22-IT
• Lead Sponsor: AOP ORPHAN PHARMACEUTICALS AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-31
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 200

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
Are the trial subjects under 18? no
Number of subjects for this age range: 1
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 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
11.Patients for whom a Do Not Resuscitate (DNR) exist
12.Known sensitivity to any component of the study medication (e.g. mannitol)
13.Participation in a clinical drug trial within 30 days prior randomization
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

Study & Design

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