Clinical trial NCT02893241: Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 2013
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension,

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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence of newly occurring HR ≥ 100 beats/min
timeFrame: during the first 15 minutes after initial drug administration of cafedrine/theodrenaline or ephedrine
measure: Weighted deviation below the individually determined, lowest systolic blood pressure BPmin
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Teva Investigational Site 133
city: Amberg
country: Germany
facility: Teva Investigational Site 122
city: Aue
country: Germany
facility: Teva Investigational Site 106
city: Augsburg
country: Germany
facility: Teva Investigational Site 116
city: Aurich
country: Germany
facility: Teva Investigational Site 165
city: Bad Hersfeld
country: Germany
facility: Teva Investigational Site 110
city: Bad Saarow
country: Germany
facility: Teva Investigational Site 134
city: Bad Soden
country: Germany
facility: Teva Investigational Site 174
city: Baden-Baden
country: Germany
facility: Teva Investigational Site 142
city: Brake
country: Germany
facility: Teva Investigational Site 121
city: Dillingen
country: Germany
facility: Teva Investigational Site 154
city: Dresden
country: Germany
facility: Teva Investigational Site 119
city: Düsseldorf
country: Germany
facility: Teva Investigational Site 171
city: Eichstätt
country: Germany
facility: Teva Investigational Site 111
city: Essen
country: Germany
facility: Teva Investigational Site 107
city: Flensburg
country: Germany
facility: Teva Investigational Site 167
city: Friedberg
country: Germany
facility: Teva Investigational Site 141
city: Fulda
country: Germany
facility: Teva Investigational Site 131
city: Gelnhausen
country: Germany
facility: Teva Investigational Site 114
city: Gelsenkirchen
country: Germany
facility: Teva Investigational Site 158
city: Gießen
country: Germany
facility: Teva Investigational Site 164
city: Greifswald
country: Germany
facility: Teva Investigational Site 159
city: Göppingen
country: Germany
facility: Teva Investigational Site 149
city: Hamburg
country: Germany
facility: Teva Investigational Site 113
city: Hamburg
country: Germany
facility: Teva Investigational Site 163
city: Hannover
country: Germany
facility: Teva Investigational Site 143
city: Hannover
country: Germany
facility: Teva Investigational Site 144
city: Hannover
country: Germany
facility: Teva Investigational Site 151
city: Heilbronn
country: Germany
facility: Teva Investigational Site 129
city: Herford
country: Germany
facility: Teva Investigational Site 112
city: Hildesheim
country: Germany
facility: Teva Investigational Site 160
city: Homburg
country: Germany
facility: Teva Investigational Site 132
city: Idar-Oberstein
country: Germany
facility: Teva Investigational Site 168
city: Jena
country: Germany
facility: Teva Investigational Site 147
city: Karlsruhe
country: Germany
facility: Teva Investigational Site 123
city: Kassel
country: Germany
facility: Teva Investigational Site 157
city: Kempen
country: Germany
facility: Teva Investigational Site 104
city: Köln
country: Germany
facility: Teva Investigational Site 146
city: Leipzig
country: Germany
facility: Teva Investigational Site 117
city: Leipzig
country: Germany
facility: Teva Investigational Site 135
city: Leverkusen
country: Germany
facility: Teva Investigational Site 118
city: Lingen
country: Germany
facility: Teva Investigational Site 102
city: Ludwigsburg
country: Germany
facility: Teva Investigational Site 109
city: Lüneburg
country: Germany
facility: Teva Investigational Site 139
city: Marburg
country: Germany
facility: Teva Investigational Site 101
city: Minden
country: Germany
facility: Teva Investigational Site 155
city: Mönchengladbach
country: Germany
facility: Teva Investigational Site 138
city: München
country: Germany
facility: Teva Investigational Site 127
city: Münster
country: Germany
facility: Teva Investigational Site 130
city: Neuruppin
country: Germany
facility: Teva Investigational Site 124
city: Nürnberg
country: Germany
facility: Teva Investigational Site 152
city: Nürnberg
country: Germany
facility: Teva Investigational Site 173
city: Oldenburg
country: Germany
facility: Teva Investigational Site 156
city: Pforzheim
country: Germany
facility: Teva Investigational Site 108
city: Pirmasens
country: Germany
facility: Teva Investigational Site 136
city: Prien am Chiemsee
country: Germany
facility: Teva Investigational Site 172
city: Rheine
country: Germany
facility: Teva Investigational Site 150
city: Rostock
country: Germany
facility: Teva Investigational Site 125
city: Saalfeld
country: Germany
facility: Teva Investigational Site 169
city: Schwalmstadt
country: Germany
facility: Teva Investigational Site 148
city: Schwerin
country: Germany
facility: Teva Investigational Site 166
city: Solingen
country: Germany
facility: Teva Investigational Site 126
city: Traunstein
country: Germany
facility: Teva Investigational Site 128
city: Trier
country: Germany
facility: Teva Investigational Site 170
city: Ulm
country: Germany
facility: Teva Investigational Site 175
city: Unna
country: Germany
facility: Teva Investigational Site 162
city: Velbert
country: Germany
facility: Teva Investigational Site 153
city: Warendorf
country: Germany
facility: Teva Investigational Site 105
city: Wesel
country: Germany
facility: Teva Investigational Site 115
city: Wetzlar
country: Germany
facility: Teva Investigational Site 140
city: Wiesbaden
country: Germany
facility: Teva Investigational Site 120
city: Worms
country: Germany
facility: Teva Investigational Site 137
city: Würzburg
country: Germany
facility: Teva Investigational Site 103
city: Zwiesel
country: Germany
facility: Teva Investigational Site 145
city: Zwiesel
country: Germany
facility: Teva Investigational Site 146
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.