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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia |
| |
| Cohort B | Patients, who undergo caesarean section under spinal anaesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cafedrine/theodrenaline | Drug |
| ||
| Ephedrine |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of newly occurring HR ≥ 100 beats/min | during the first 15 minutes after initial drug administration of cafedrine/theodrenaline or ephedrine | |
| Weighted deviation below the individually determined, lowest systolic blood pressure BPmin | within the first 15 minutes after the initial delivery of the antihypotonic drug as area1 (AUC) between the systolic blood pressure curve (below BPmin) and the lower limit BPmin |
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Inclusion Criteria:
Cohort A:
Cohort B:
Exclusion Criteria:
Contraindication to the use of cafedrine/theodrenaline or ephedrine (Ephedrin Meduna) in accordance with current German specialist information
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:
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Hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension,
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 133 | Aachen | Germany | ||||
| Teva Investigational Site 122 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33625060 | Derived | 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. | |
| 29415580 |
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|
| 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000147 | cafedrine, theodrenaline drug combination |
| D004809 | Ephedrine |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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