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

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ClinicalTrials.gov Identifier: NCT02893241
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Ratiopharm GmbH )

Study Description
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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.

Condition or disease Intervention/treatment
Hypotension Drug: Cafedrine/theodrenaline Drug: Ephedrine

Study Design
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Study Type : Observational
Actual Enrollment : 2013 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 30, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension,
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893241


Locations
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Sponsors and Collaborators
Ratiopharm GmbH
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ratiopharm GmbH
ClinicalTrials.gov Identifier: NCT02893241    
Other Study ID Numbers: TV48531-CV-40092
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Cafedrine
Theodrenaline
Ephedrine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
 Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Vasodilator Agents