Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting
- Registration Number
- NCT02893241
- Lead Sponsor
- Ratiopharm GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2013
- 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
-
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort A Cafedrine/theodrenaline Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia Cohort A Ephedrine Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia Cohort B Ephedrine Patients, who undergo caesarean section under spinal anaesthesia Cohort B Cafedrine/theodrenaline Patients, who undergo caesarean section under spinal anaesthesia
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (74)
Teva Investigational Site 122
🇩🇪Amberg, Germany
Teva Investigational Site 106
🇩🇪Aue, Germany
Teva Investigational Site 133
🇩🇪Aachen, Germany
Teva Investigational Site 116
🇩🇪Augsburg, Germany
Teva Investigational Site 134
🇩🇪Bad Saarow, Germany
Teva Investigational Site 174
🇩🇪Bad Soden, Germany
Teva Investigational Site 121
🇩🇪Brake, Germany
Teva Investigational Site 142
🇩🇪Baden-Baden, 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 141
🇩🇪Friedberg, Germany
Teva Investigational Site 107
🇩🇪Essen, Germany
Teva Investigational Site 167
🇩🇪Flensburg, Germany
Teva Investigational Site 114
🇩🇪Gelnhausen, Germany
Teva Investigational Site 158
🇩🇪Gelsenkirchen, Germany
Teva Investigational Site 159
🇩🇪Greifswald, Germany
Teva Investigational Site 164
🇩🇪Gießen, Germany
Teva Investigational Site 149
🇩🇪Göppingen, Germany
Teva Investigational Site 113
🇩🇪Hamburg, Germany
Teva Investigational Site 163
🇩🇪Hamburg, Germany
Teva Investigational Site 143
🇩🇪Hannover, Germany
Teva Investigational Site 151
🇩🇪Hannover, Germany
Teva Investigational Site 144
🇩🇪Hannover, Germany
Teva Investigational Site 129
🇩🇪Heilbronn, Germany
Teva Investigational Site 112
🇩🇪Herford, Germany
Teva Investigational Site 147
🇩🇪Jena, Germany
Teva Investigational Site 160
🇩🇪Hildesheim, Germany
Teva Investigational Site 123
🇩🇪Karlsruhe, Germany
Teva Investigational Site 168
🇩🇪Idar-Oberstein, Germany
Teva Investigational Site 146
🇩🇪Zwiesel, 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 101
🇩🇪Marburg, Germany
Teva Investigational Site 155
🇩🇪Minden, Germany
Teva Investigational Site 109
🇩🇪Ludwigsburg, Germany
Teva Investigational Site 139
🇩🇪Lüneburg, Germany
Teva Investigational Site 124
🇩🇪Neuruppin, Germany
Teva Investigational Site 169
🇩🇪Saalfeld, Germany
Teva Investigational Site 127
🇩🇪München, Germany
Teva Investigational Site 152
🇩🇪Nürnberg, Germany
Teva Investigational Site 138
🇩🇪Mönchengladbach, Germany
Teva Investigational Site 130
🇩🇪Münster, Germany
Teva Investigational Site 136
🇩🇪Pirmasens, Germany
Teva Investigational Site 125
🇩🇪Rostock, Germany
Teva Investigational Site 156
🇩🇪Oldenburg, Germany
Teva Investigational Site 108
🇩🇪Pforzheim, Germany
Teva Investigational Site 172
🇩🇪Prien am Chiemsee, Germany
Teva Investigational Site 150
🇩🇪Rheine, Germany
Teva Investigational Site 148
🇩🇪Schwalmstadt, Germany
Teva Investigational Site 126
🇩🇪Solingen, Germany
Teva Investigational Site 128
🇩🇪Traunstein, Germany
Teva Investigational Site 166
🇩🇪Schwerin, Germany
Teva Investigational Site 175
🇩🇪Ulm, Germany
Teva Investigational Site 120
🇩🇪Wiesbaden, Germany
Teva Investigational Site 170
🇩🇪Trier, Germany
Teva Investigational Site 162
🇩🇪Unna, Germany
Teva Investigational Site 153
🇩🇪Velbert, Germany
Teva Investigational Site 105
🇩🇪Warendorf, Germany
Teva Investigational Site 103
🇩🇪Würzburg, Germany
Teva Investigational Site 145
🇩🇪Zwiesel, Germany
Teva Investigational Site 137
🇩🇪Worms, Germany
Teva Investigational Site 131
🇩🇪Fulda, Germany
Teva Investigational Site 132
🇩🇪Homburg, Germany
Teva Investigational Site 110
🇩🇪Bad Hersfeld, Germany
Teva Investigational Site 165
🇩🇪Aurich, Germany
Teva Investigational Site 173
🇩🇪Nürnberg, Germany
Teva Investigational Site 115
🇩🇪Wesel, Germany
Teva Investigational Site 140
🇩🇪Wetzlar, Germany