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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02893241
Other study ID # TV48531-CV-40092
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2016
Est. completion date December 31, 2017

Study information

Verified date November 2021
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cafedrine/theodrenaline

Ephedrine


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Ratiopharm GmbH

Country where clinical trial is conducted

Germany, 

Outcome

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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