Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting

Last updated: November 5, 2021
Sponsor: Ratiopharm GmbH
Overall Status: Completed

Phase

N/A

Condition

Dizzy/fainting Spells

Circulation Disorders

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT02893241
TV48531-CV-40092
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inpatients, who received IV treatment (bolus administration) withcafedrine/theodrenaline or ephedrine (Ephedrin Meduna) due to an acute arterialhypotension
  • Consent to use of data is available
  • Patient under careful blood pressure and pulse monitoring (at least 2 minutesmeasuring interval (BP/HR) and/or at least 7 measurements within the first 15 minutesafter 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

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 otheranti-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

Total Participants: 2013
Study Start date:
April 30, 2016
Estimated Completion Date:
December 31, 2017

Connect with a study center

  • Teva Investigational Site 133

    Aachen,
    Germany

    Site Not Available

  • Teva Investigational Site 122

    Amberg,
    Germany

    Site Not Available

  • Teva Investigational Site 106

    Aue,
    Germany

    Site Not Available

  • Teva Investigational Site 116

    Augsburg,
    Germany

    Site Not Available

  • Teva Investigational Site 165

    Aurich,
    Germany

    Site Not Available

  • Teva Investigational Site 110

    Bad Hersfeld,
    Germany

    Site Not Available

  • Teva Investigational Site 134

    Bad Saarow,
    Germany

    Site Not Available

  • Teva Investigational Site 174

    Bad Soden,
    Germany

    Site Not Available

  • Teva Investigational Site 174

    Bad Soden Am Taunus,
    Germany

    Site Not Available

  • Teva Investigational Site 142

    Baden-Baden,
    Germany

    Site Not Available

  • Teva Investigational Site 121

    Brake,
    Germany

    Site Not Available

  • Teva Investigational Site 154

    Dillingen,
    Germany

    Site Not Available

  • Teva Investigational Site 119

    Dresden,
    Germany

    Site Not Available

  • Teva Investigational Site 171

    Düsseldorf,
    Germany

    Site Not Available

  • Teva Investigational Site 111

    Eichstätt,
    Germany

    Site Not Available

  • Teva Investigational Site 107

    Essen,
    Germany

    Site Not Available

  • Teva Investigational Site 167

    Flensburg,
    Germany

    Site Not Available

  • Teva Investigational Site 141

    Friedberg,
    Germany

    Site Not Available

  • Teva Investigational Site 131

    Fulda,
    Germany

    Site Not Available

  • Teva Investigational Site 114

    Gelnhausen,
    Germany

    Site Not Available

  • Teva Investigational Site 158

    Gelsenkirchen,
    Germany

    Site Not Available

  • Teva Investigational Site 164

    Gießen,
    Germany

    Site Not Available

  • Teva Investigational Site 159

    Greifswald,
    Germany

    Site Not Available

  • Teva Investigational Site 149

    Göppingen,
    Germany

    Site Not Available

  • Teva Investigational Site 113

    Hamburg,
    Germany

    Site Not Available

  • Teva Investigational Site 163

    Hamburg,
    Germany

    Site Not Available

  • Teva Investigational Site 143

    Hannover,
    Germany

    Site Not Available

  • Teva Investigational Site 144

    Hannover,
    Germany

    Site Not Available

  • Teva Investigational Site 151

    Hannover,
    Germany

    Site Not Available

  • Teva Investigational Site 129

    Heilbronn,
    Germany

    Site Not Available

  • Teva Investigational Site 112

    Herford,
    Germany

    Site Not Available

  • Teva Investigational Site 160

    Hildesheim,
    Germany

    Site Not Available

  • Teva Investigational Site 132

    Homburg,
    Germany

    Site Not Available

  • Teva Investigational Site 168

    Idar-Oberstein,
    Germany

    Site Not Available

  • Teva Investigational Site 147

    Jena,
    Germany

    Site Not Available

  • Teva Investigational Site 123

    Karlsruhe,
    Germany

    Site Not Available

  • Teva Investigational Site 157

    Kassel,
    Germany

    Site Not Available

  • Teva Investigational Site 104

    Kempen,
    Germany

    Site Not Available

  • Teva Investigational Site 146

    Köln,
    Germany

    Site Not Available

  • Teva Investigational Site 117

    Leipzig,
    Germany

    Site Not Available

  • Teva Investigational Site 135

    Leipzig,
    Germany

    Site Not Available

  • Teva Investigational Site 118

    Leverkusen,
    Germany

    Site Not Available

  • Teva Investigational Site 102

    Lingen,
    Germany

    Site Not Available

  • Teva Investigational Site 109

    Ludwigsburg,
    Germany

    Site Not Available

  • Teva Investigational Site 139

    Lüneburg,
    Germany

    Site Not Available

  • Teva Investigational Site 101

    Marburg,
    Germany

    Site Not Available

  • Teva Investigational Site 155

    Minden,
    Germany

    Site Not Available

  • Teva Investigational Site 138

    Mönchengladbach,
    Germany

    Site Not Available

  • Teva Investigational Site 127

    München,
    Germany

    Site Not Available

  • Teva Investigational Site 130

    Münster,
    Germany

    Site Not Available

  • Teva Investigational Site 124

    Neuruppin,
    Germany

    Site Not Available

  • Teva Investigational Site 152

    Nürnberg,
    Germany

    Site Not Available

  • Teva Investigational Site 173

    Nürnberg,
    Germany

    Site Not Available

  • Teva Investigational Site 156

    Oldenburg,
    Germany

    Site Not Available

  • Teva Investigational Site 108

    Pforzheim,
    Germany

    Site Not Available

  • Teva Investigational Site 136

    Pirmasens,
    Germany

    Site Not Available

  • Teva Investigational Site 172

    Prien am Chiemsee,
    Germany

    Site Not Available

  • Teva Investigational Site 150

    Rheine,
    Germany

    Site Not Available

  • Teva Investigational Site 125

    Rostock,
    Germany

    Site Not Available

  • Teva Investigational Site 169

    Saalfeld,
    Germany

    Site Not Available

  • Teva Investigational Site 148

    Schwalmstadt,
    Germany

    Site Not Available

  • Teva Investigational Site 166

    Schwerin,
    Germany

    Site Not Available

  • Teva Investigational Site 126

    Solingen,
    Germany

    Site Not Available

  • Teva Investigational Site 128

    Traunstein,
    Germany

    Site Not Available

  • Teva Investigational Site 170

    Trier,
    Germany

    Site Not Available

  • Teva Investigational Site 175

    Ulm,
    Germany

    Site Not Available

  • Teva Investigational Site 162

    Unna,
    Germany

    Site Not Available

  • Teva Investigational Site 153

    Velbert,
    Germany

    Site Not Available

  • Teva Investigational Site 105

    Warendorf,
    Germany

    Site Not Available

  • Teva Investigational Site 115

    Wesel,
    Germany

    Site Not Available

  • Teva Investigational Site 140

    Wetzlar,
    Germany

    Site Not Available

  • Teva Investigational Site 120

    Wiesbaden,
    Germany

    Site Not Available

  • Teva Investigational Site 137

    Worms,
    Germany

    Site Not Available

  • Teva Investigational Site 161

    Wuppertal,
    Germany

    Site Not Available

  • Teva Investigational Site 103

    Würzburg,
    Germany

    Site Not Available

  • Teva Investigational Site 145

    Zwiesel,
    Germany

    Site Not Available

  • Teva Investigational Site 146

    Zwiesel,
    Germany

    Site Not Available

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