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

November 5, 2021 updated by: Ratiopharm GmbH

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2013

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • Teva Investigational Site 133
      • Amberg, Germany
        • Teva Investigational Site 122
      • Aue, Germany
        • Teva Investigational Site 106
      • Augsburg, Germany
        • Teva Investigational Site 116
      • Aurich, Germany
        • Teva Investigational Site 165
      • Bad Hersfeld, Germany
        • Teva Investigational Site 110
      • Bad Saarow, Germany
        • Teva Investigational Site 134
      • Bad Soden, Germany
        • Teva Investigational Site 174
      • Baden-Baden, Germany
        • Teva Investigational Site 142
      • Brake, Germany
        • Teva Investigational Site 121
      • Dillingen, Germany
        • Teva Investigational Site 154
      • Dresden, Germany
        • Teva Investigational Site 119
      • Düsseldorf, Germany
        • Teva Investigational Site 171
      • Eichstätt, Germany
        • Teva Investigational Site 111
      • Essen, Germany
        • Teva Investigational Site 107
      • Flensburg, Germany
        • Teva Investigational Site 167
      • Friedberg, Germany
        • Teva Investigational Site 141
      • Fulda, Germany
        • Teva Investigational Site 131
      • Gelnhausen, Germany
        • Teva Investigational Site 114
      • Gelsenkirchen, Germany
        • Teva Investigational Site 158
      • Gießen, Germany
        • Teva Investigational Site 164
      • Greifswald, Germany
        • Teva Investigational Site 159
      • Göppingen, Germany
        • Teva Investigational Site 149
      • Hamburg, Germany
        • Teva Investigational Site 113
      • Hamburg, Germany
        • Teva Investigational Site 163
      • Hannover, Germany
        • Teva Investigational Site 143
      • Hannover, Germany
        • Teva Investigational Site 144
      • Hannover, Germany
        • Teva Investigational Site 151
      • Heilbronn, Germany
        • Teva Investigational Site 129
      • Herford, Germany
        • Teva Investigational Site 112
      • Hildesheim, Germany
        • Teva Investigational Site 160
      • Homburg, Germany
        • Teva Investigational Site 132
      • Idar-Oberstein, Germany
        • Teva Investigational Site 168
      • Jena, Germany
        • Teva Investigational Site 147
      • Karlsruhe, Germany
        • Teva Investigational Site 123
      • Kassel, Germany
        • Teva Investigational Site 157
      • Kempen, Germany
        • Teva Investigational Site 104
      • Köln, Germany
        • Teva Investigational Site 146
      • Leipzig, Germany
        • Teva Investigational Site 117
      • Leipzig, Germany
        • Teva Investigational Site 135
      • Leverkusen, Germany
        • Teva Investigational Site 118
      • Lingen, Germany
        • Teva Investigational Site 102
      • Ludwigsburg, Germany
        • Teva Investigational Site 109
      • Lüneburg, Germany
        • Teva Investigational Site 139
      • Marburg, Germany
        • Teva Investigational Site 101
      • Minden, Germany
        • Teva Investigational Site 155
      • Mönchengladbach, Germany
        • Teva Investigational Site 138
      • München, Germany
        • Teva Investigational Site 127
      • Münster, Germany
        • Teva Investigational Site 130
      • Neuruppin, Germany
        • Teva Investigational Site 124
      • Nürnberg, Germany
        • Teva Investigational Site 152
      • Nürnberg, Germany
        • Teva Investigational Site 173
      • Oldenburg, Germany
        • Teva Investigational Site 156
      • Pforzheim, Germany
        • Teva Investigational Site 108
      • Pirmasens, Germany
        • Teva Investigational Site 136
      • Prien am Chiemsee, Germany
        • Teva Investigational Site 172
      • Rheine, Germany
        • Teva Investigational Site 150
      • Rostock, Germany
        • Teva Investigational Site 125
      • Saalfeld, Germany
        • Teva Investigational Site 169
      • Schwalmstadt, Germany
        • Teva Investigational Site 148
      • Schwerin, Germany
        • Teva Investigational Site 166
      • Solingen, Germany
        • Teva Investigational Site 126
      • Traunstein, Germany
        • Teva Investigational Site 128
      • Trier, Germany
        • Teva Investigational Site 170
      • Ulm, Germany
        • Teva Investigational Site 175
      • Unna, Germany
        • Teva Investigational Site 162
      • Velbert, Germany
        • Teva Investigational Site 153
      • Warendorf, Germany
        • Teva Investigational Site 105
      • Wesel, Germany
        • Teva Investigational Site 115
      • Wetzlar, Germany
        • Teva Investigational Site 140
      • Wiesbaden, Germany
        • Teva Investigational Site 120
      • Worms, Germany
        • Teva Investigational Site 137
      • Würzburg, Germany
        • Teva Investigational Site 103
      • Zwiesel, Germany
        • Teva Investigational Site 145
      • Zwiesel, Germany
        • Teva Investigational Site 146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort A
Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia
Drug: Ephedrine
Drug: Cafedrine/theodrenaline
Cohort B
Patients, who undergo caesarean section under spinal anaesthesia
Drug: Ephedrine
Drug: Cafedrine/theodrenaline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ratiopharm GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TV48531-CV-40092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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