Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting: a Multicenter, Prospective, Non-interventional Study
Data Collection
Collected from today forward - ProspectiveCardiovascular Diseases
+ Hypotension
+ Vascular Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 30, 2016
Actual date on which the first participant was enrolled.This is a national, multicentre, prospective, open, two-arm, non-interventional study with hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension, wherein the patients are assigned to a treatment arm based on the department.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2013 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Inpatients, who received IV treatment (bolus administration) with cafedrine/theodrenaline or ephedrine (Ephedrin Meduna) due to an acute arterial hypotension * Consent to use of data is available * Patient under careful blood pressure and pulse monitoring (at least 2 minutes measuring interval (BP/HR) and/or at least 7 measurements within the first 15 minutes after the first application of cafedrine/theodrenaline or ephedrine) Cohort A: * Treatment of hypotension in \< 100 mm Hg syst. and/or drop in blood pressure \> 20% syst. compared to preoperative base value (syst.) * Patients ≥ 50 years old * Pre-existing comorbidities (ASA classification 2-4) * Elective surgery * General anaesthesia with propofol/fentanyl ≥ 0.2 mg (or equivalent) Cohort B: * Treatment of hypotension in \< 100 mm Hg syst. and/or drop in blood pressure \> 10% syst. compared to preoperative base value (syst.) * Patients ≥ 18 years old * Caesarean section under spinal anaesthesia Exclusion Criteria: * Contraindication to the use of cafedrine/theodrenaline or ephedrine (Ephedrin Meduna) in accordance with current German specialist information * Hypersensitivity to any product ingredient * Hypertensive blood pressure readings * Mitral stenosis * Narrow-angle glaucoma * Hyperthyroidism * Pheochromocytoma * Prostatic adenoma with urinary retention * Bronchial asthmatics with sulphite sensitivity * Hyper-excitability * Arteriosclerosis * Aneurysm * Treatment with other indirect sympathomimetic drugs (Example: phenylpropanolamine, phenylephrine, pseudoephedrine or methylphenidate) * Use of Monoamine oxidase (MAO) inhibitors (including within the last two weeks) * Prophylactic administration of cafedrine/theodrenaline or ephedrine or other anti-hypertensives * Sepsis, septic shock or systemic inflammatory response syndrome (SIRS) Cohort A: • Intra-cranial surgery or heart surgery Cohort B: * High-risk pregnancy (emergency Caesarean, severe infantile malformation) * Multiple pregnancy * Amniotic infection syndrome
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 75 locations
Teva Investigational Site 133
Aachen, GermanyTeva Investigational Site 122
Amberg, GermanyTeva Investigational Site 106
Aue, Germany