HypotensionNCT02893241
Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting
An observational study of Hypotension, run by Ratiopharm GmbH at 75 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hypotension
- What is being tested?
- Cafedrine/theodrenaline and Ephedrine
- How many people
- 2,013 participants
- Where
- 75 sitesGermany
- Study dates
- 30 Apr 2016to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension,
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
75 sites in 1 country.
75 sites in 1 country
Germany75 sites
Teva Investigational Site 133
Aachen
Teva Investigational Site 122
Amberg
Teva Investigational Site 106
Aue
Teva Investigational Site 116
Augsburg
Teva Investigational Site 165
Aurich
Teva Investigational Site 110
Bad Hersfeld
Teva Investigational Site 134
Bad Saarow
Teva Investigational Site 174
Bad Soden
Teva Investigational Site 142
Baden-Baden
Teva Investigational Site 121
Brake
Teva Investigational Site 146
Cologne
Teva Investigational Site 154
Dillingen
Teva Investigational Site 119
Dresden
Teva Investigational Site 171
Düsseldorf
Teva Investigational Site 111
Eichstätt
Teva Investigational Site 107
Essen
Teva Investigational Site 167
Flensburg
Teva Investigational Site 141
Friedberg
Teva Investigational Site 131
Fulda
Teva Investigational Site 114
Gelnhausen
Teva Investigational Site 158
Gelsenkirchen
Teva Investigational Site 164
Giessen
Teva Investigational Site 149
Göppingen
Teva Investigational Site 159
Greifswald
Teva Investigational Site 113
Hamburg
Teva Investigational Site 163
Hamburg
Teva Investigational Site 143
Hanover
Teva Investigational Site 144
Hanover
Teva Investigational Site 151
Hanover
Teva Investigational Site 129
Heilbronn
Teva Investigational Site 112
Herford
Teva Investigational Site 160
Hildesheim
Teva Investigational Site 132
Homburg
Teva Investigational Site 168
Idar-Oberstein
Teva Investigational Site 147
Jena
Teva Investigational Site 123
Karlsruhe
Teva Investigational Site 157
Kassel
Teva Investigational Site 104
Kempen
Teva Investigational Site 117
Leipzig
Teva Investigational Site 135
Leipzig
Teva Investigational Site 118
Leverkusen
Teva Investigational Site 102
Lingen
Teva Investigational Site 109
Ludwigsburg
Teva Investigational Site 139
Lüneburg
Teva Investigational Site 101
Marburg
Teva Investigational Site 155
Minden
Teva Investigational Site 138
Mönchengladbach
Teva Investigational Site 127
München
Teva Investigational Site 130
Münster
Teva Investigational Site 124
Neuruppin
Teva Investigational Site 152
Nuremberg
Teva Investigational Site 173
Nuremberg
Teva Investigational Site 156
Oldenburg
Teva Investigational Site 108
Pforzheim
Teva Investigational Site 136
Pirmasens
Teva Investigational Site 172
Prien am Chiemsee
Teva Investigational Site 150
Rheine
Teva Investigational Site 125
Rostock
Teva Investigational Site 169
Saalfeld
Teva Investigational Site 148
Schwalmstadt
Teva Investigational Site 166
Schwerin
Teva Investigational Site 126
Solingen
Teva Investigational Site 128
Traunstein
Teva Investigational Site 170
Trier
Teva Investigational Site 175
Ulm
Teva Investigational Site 162
Unna
Teva Investigational Site 153
Velbert
Teva Investigational Site 105
Warendorf
Teva Investigational Site 115
Wesel
Teva Investigational Site 140
Wetzlar
Teva Investigational Site 120
Wiesbaden
Teva Investigational Site 137
Worms
Teva Investigational Site 103
Würzburg
Teva Investigational Site 145
Zwiesel
Teva Investigational Site 146
Zwiesel
About this study
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
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
- Being tested
- Cafedrine/theodrenaline, Ephedrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cafedrine/theodrenalineDrug
EphedrineDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia Receives: Drug: Cafedrine/theodrenaline; Drug: Ephedrine | |
| Cohort B | Patients, who undergo caesarean section under spinal anaesthesia Receives: Drug: Cafedrine/theodrenaline; Drug: Ephedrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of newly occurring HR ≥ 100 beats/min
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start30 Apr 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ratiopharm GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893241
- Sponsor's protocol ID
- TV48531-CV-40092
- Status last verified
- Nov 2021
- First submitted
- 2 Sep 2016
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33625060Eberhart 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.
PubMed 29415580
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02893241
- Acronym / sponsor ID
- TV48531-CV-40092
- Conditions
- Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,013 participants (actual)
- Lead sponsor
- Ratiopharm GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: Cafedrine/theodrenaline, Drug: EphedrinePatients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia |
| Cohort B | – | Drug: Cafedrine/theodrenaline, Drug: EphedrinePatients, who undergo caesarean section under spinal anaesthesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension,
Key inclusion criteria (13 listed)
- 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)
- 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
Key exclusion criteria (22 listed)
- Contraindication to the use of cafedrine/theodrenaline or ephedrine (Ephedrin Meduna) in accordance with current German specialist information
- Prophylactic administration of cafedrine/theodrenaline or ephedrine or other anti-hypertensives
- Sepsis, septic shock or systemic inflammatory response syndrome (SIRS)
- Intra-cranial surgery or heart surgery
- High-risk pregnancy (emergency Caesarean, severe infantile malformation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cafedrine/theodrenaline | Drug | Cohort A, Cohort B |
| Ephedrine | Drug | Cohort A, Cohort B |
Primary outcome
The incidence of newly occurring HR ≥ 100 beats/min
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Derived from this study: PubMed 33625060Kranke 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.
- Derived from this study: PubMed 29415580Eberhart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
75 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension, run by Ratiopharm GmbH at 75 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of newly occurring HR ≥ 100 beats/min (time frame: during the first 15 minutes after initial drug administration of cafedrine/theodrenaline or ephedrine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893241, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.