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

NCT02893241 | Completed

• 1 other identifier: TV48531-CV-40092
• Study Type: observational
• Target: 2,013
• Locations: 1 country
• Sites: 75

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cohort A

Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia

Drug: Cafedrine/theodrenaline; Drug: Ephedrine

Cohort B

Patients, who undergo caesarean section under spinal anaesthesia

Drug: Cafedrine/theodrenaline; Drug: Ephedrine

Interventions

Cafedrine/theodrenaline DRUG

Cohort A; Cohort B

Ephedrine DRUG

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension,

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ratiopharm GmbH: lead

Study Sites (75)

Teva Investigational Site 133

Aachen, Germany

Location

Teva Investigational Site 122

Amberg, Germany

Location

Teva Investigational Site 106

Aue, Germany

Location

Teva Investigational Site 116

Augsburg, Germany

Location

Teva Investigational Site 165

Aurich, Germany

Location

Teva Investigational Site 110

Bad Hersfeld, Germany

Location

Teva Investigational Site 134

Bad Saarow, Germany

Location

Teva Investigational Site 174

Bad Soden, Germany

Location

Teva Investigational Site 142

Baden-Baden, Germany

Location

Teva Investigational Site 121

Brake, Germany

Location

Teva Investigational Site 146

Cologne, Germany

Location

Teva Investigational Site 154

Dillingen, Germany

Location

Teva Investigational Site 119

Dresden, Germany

Location

Teva Investigational Site 171

Düsseldorf, Germany

Location

Teva Investigational Site 111

Eichstätt, Germany

Location

Teva Investigational Site 107

Essen, Germany

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Teva Investigational Site 167

Flensburg, Germany

Location

Teva Investigational Site 141

Friedberg, Germany

Location

Teva Investigational Site 131

Fulda, Germany

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Teva Investigational Site 114

Gelnhausen, Germany

Location

Teva Investigational Site 158

Gelsenkirchen, Germany

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Teva Investigational Site 164

Giessen, Germany

Location

Teva Investigational Site 149

Göppingen, Germany

Location

Teva Investigational Site 159

Greifswald, Germany

Location

Teva Investigational Site 113

Hamburg, Germany

Location

Teva Investigational Site 163

Hamburg, Germany

Location

Teva Investigational Site 143

Hanover, Germany

Location

Teva Investigational Site 144

Hanover, Germany

Location

Teva Investigational Site 151

Hanover, Germany

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Teva Investigational Site 129

Heilbronn, Germany

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Teva Investigational Site 112

Herford, Germany

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Teva Investigational Site 160

Hildesheim, Germany

Location

Teva Investigational Site 132

Homburg, Germany

Location

Teva Investigational Site 168

Idar-Oberstein, Germany

Location

Teva Investigational Site 147

Jena, Germany

Location

Teva Investigational Site 123

Karlsruhe, Germany

Location

Teva Investigational Site 157

Kassel, Germany

Location

Teva Investigational Site 104

Kempen, Germany

Location

Teva Investigational Site 117

Leipzig, Germany

Location

Teva Investigational Site 135

Leipzig, Germany

Location

Teva Investigational Site 118

Leverkusen, Germany

Location

Teva Investigational Site 102

Lingen, Germany

Location

Teva Investigational Site 109

Ludwigsburg, Germany

Location

Teva Investigational Site 139

Lüneburg, Germany

Location

Teva Investigational Site 101

Marburg, Germany

Location

Teva Investigational Site 155

Minden, Germany

Location

Teva Investigational Site 138

Mönchengladbach, Germany

Location

Teva Investigational Site 127

München, Germany

Location

Teva Investigational Site 130

Münster, Germany

Location

Teva Investigational Site 124

Neuruppin, Germany

Location

Teva Investigational Site 152

Nuremberg, Germany

Location

Teva Investigational Site 173

Nuremberg, Germany

Location

Teva Investigational Site 156

Oldenburg, Germany

Location

Teva Investigational Site 108

Pforzheim, Germany

Location

Teva Investigational Site 136

Pirmasens, Germany

Location

Teva Investigational Site 172

Prien am Chiemsee, Germany

Location

Teva Investigational Site 150

Rheine, Germany

Location

Teva Investigational Site 125

Rostock, Germany

Location

Teva Investigational Site 169

Saalfeld, Germany

Location

Teva Investigational Site 148

Schwalmstadt, Germany

Location

Teva Investigational Site 166

Schwerin, Germany

Location

Teva Investigational Site 126

Solingen, Germany

Location

Teva Investigational Site 128

Traunstein, Germany

Location

Teva Investigational Site 170

Trier, Germany

Location

Teva Investigational Site 175

Ulm, Germany

Location

Teva Investigational Site 162

Unna, Germany

Location

Teva Investigational Site 153

Velbert, Germany

Location

Teva Investigational Site 105

Warendorf, Germany

Location

Teva Investigational Site 115

Wesel, Germany

Location

Teva Investigational Site 140

Wetzlar, Germany

Location

Teva Investigational Site 120

Wiesbaden, Germany

Location

Teva Investigational Site 137

Worms, Germany

Location

Teva Investigational Site 103

Würzburg, Germany

Location

Teva Investigational Site 145

Zwiesel, Germany

Location

Teva Investigational Site 146

Zwiesel, Germany

Location

Related Publications (2)

• 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.

  PMID: 33625060 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.

  PMID: 29415580 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

cafedrine, theodrenaline drug combination; Ephedrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 8, 2016
• Study Start: April 30, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

DE (75)