Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting
NCT ID: NCT02893241
Last Updated: 2021-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2013 participants
OBSERVATIONAL
2016-04-30
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A
Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia
Cafedrine/theodrenaline
Ephedrine
Cohort B
Patients, who undergo caesarean section under spinal anaesthesia
Cafedrine/theodrenaline
Ephedrine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cafedrine/theodrenaline
Ephedrine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ratiopharm GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Teva Investigational Site 133
Aachen, , Germany
Teva Investigational Site 122
Amberg, , Germany
Teva Investigational Site 106
Aue, , Germany
Teva Investigational Site 116
Augsburg, , Germany
Teva Investigational Site 165
Aurich, , Germany
Teva Investigational Site 110
Bad Hersfeld, , Germany
Teva Investigational Site 134
Bad Saarow, , Germany
Teva Investigational Site 174
Bad Soden, , Germany
Teva Investigational Site 142
Baden-Baden, , Germany
Teva Investigational Site 121
Brake, , Germany
Teva Investigational Site 146
Cologne, , Germany
Teva Investigational Site 154
Dillingen, , Germany
Teva Investigational Site 119
Dresden, , Germany
Teva Investigational Site 171
Düsseldorf, , Germany
Teva Investigational Site 111
Eichstätt, , Germany
Teva Investigational Site 107
Essen, , Germany
Teva Investigational Site 167
Flensburg, , Germany
Teva Investigational Site 141
Friedberg, , Germany
Teva Investigational Site 131
Fulda, , Germany
Teva Investigational Site 114
Gelnhausen, , Germany
Teva Investigational Site 158
Gelsenkirchen, , Germany
Teva Investigational Site 164
Giessen, , Germany
Teva Investigational Site 149
Göppingen, , Germany
Teva Investigational Site 159
Greifswald, , Germany
Teva Investigational Site 113
Hamburg, , Germany
Teva Investigational Site 163
Hamburg, , Germany
Teva Investigational Site 143
Hanover, , Germany
Teva Investigational Site 144
Hanover, , Germany
Teva Investigational Site 151
Hanover, , Germany
Teva Investigational Site 129
Heilbronn, , Germany
Teva Investigational Site 112
Herford, , Germany
Teva Investigational Site 160
Hildesheim, , Germany
Teva Investigational Site 132
Homburg, , Germany
Teva Investigational Site 168
Idar-Oberstein, , Germany
Teva Investigational Site 147
Jena, , Germany
Teva Investigational Site 123
Karlsruhe, , Germany
Teva Investigational Site 157
Kassel, , Germany
Teva Investigational Site 104
Kempen, , Germany
Teva Investigational Site 117
Leipzig, , Germany
Teva Investigational Site 135
Leipzig, , Germany
Teva Investigational Site 118
Leverkusen, , Germany
Teva Investigational Site 102
Lingen, , Germany
Teva Investigational Site 109
Ludwigsburg, , Germany
Teva Investigational Site 139
Lüneburg, , Germany
Teva Investigational Site 101
Marburg, , Germany
Teva Investigational Site 155
Minden, , Germany
Teva Investigational Site 138
Mönchengladbach, , Germany
Teva Investigational Site 127
München, , Germany
Teva Investigational Site 130
Münster, , Germany
Teva Investigational Site 124
Neuruppin, , Germany
Teva Investigational Site 152
Nuremberg, , Germany
Teva Investigational Site 173
Nuremberg, , Germany
Teva Investigational Site 156
Oldenburg, , Germany
Teva Investigational Site 108
Pforzheim, , Germany
Teva Investigational Site 136
Pirmasens, , Germany
Teva Investigational Site 172
Prien am Chiemsee, , Germany
Teva Investigational Site 150
Rheine, , Germany
Teva Investigational Site 125
Rostock, , Germany
Teva Investigational Site 169
Saalfeld, , Germany
Teva Investigational Site 148
Schwalmstadt, , Germany
Teva Investigational Site 166
Schwerin, , Germany
Teva Investigational Site 126
Solingen, , Germany
Teva Investigational Site 128
Traunstein, , Germany
Teva Investigational Site 170
Trier, , Germany
Teva Investigational Site 175
Ulm, , Germany
Teva Investigational Site 162
Unna, , Germany
Teva Investigational Site 153
Velbert, , Germany
Teva Investigational Site 105
Warendorf, , Germany
Teva Investigational Site 115
Wesel, , Germany
Teva Investigational Site 140
Wetzlar, , Germany
Teva Investigational Site 120
Wiesbaden, , Germany
Teva Investigational Site 137
Worms, , Germany
Teva Investigational Site 103
Würzburg, , Germany
Teva Investigational Site 145
Zwiesel, , Germany
Teva Investigational Site 146
Zwiesel, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kranke P, Geldner G, Kienbaum P, Gerbershagen HJ, Chappell D, Wallenborn J, Huljic S, Koch T, Keller T, Weber S, Kunitz O, Linstedt U, Eberhart LHJ; HYPOTENS study group. Treatment of spinal anaesthesia-induced hypotension with cafedrine/theodrenaline versus ephedrine during caesarean section: Results from HYPOTENS, a national, multicentre, prospective, noninterventional study. Eur J Anaesthesiol. 2021 Oct 1;38(10):1067-1076. doi: 10.1097/EJA.0000000000001474.
Eberhart L, Geldner G, Huljic S, Marggraf K, Keller T, Koch T, Kranke P. A non-interventional comparative study of the 20:1 combination of cafedrine/theodrenaline versus ephedrine for the treatment of intra-operative arterial hypotension: the 'HYPOTENS' study design and rationale. Curr Med Res Opin. 2018 Jun;34(6):953-961. doi: 10.1080/03007995.2018.1438379. Epub 2018 Feb 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TV48531-CV-40092
Identifier Type: -
Identifier Source: org_study_id