Hypotension Clinical Trial
Official title:
Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting: a Multicenter, Prospective, Non-interventional Study
Verified date | November 2021 |
Source | Teva Branded Pharmaceutical Products R&D, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2013 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | 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 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 | Hannover | |
Germany | Teva Investigational Site 144 | Hannover | |
Germany | Teva Investigational Site 151 | Hannover | |
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 146 | Köln | |
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 | Nürnberg | |
Germany | Teva Investigational Site 173 | Nürnberg | |
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 |
Lead Sponsor | Collaborator |
---|---|
Ratiopharm GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of newly occurring HR = 100 beats/min | during the first 15 minutes after initial drug administration of cafedrine/theodrenaline or ephedrine | ||
Primary | 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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