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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Tracking Information
First Submitted Date September 2, 2016
First Posted Date September 8, 2016
Last Update Posted Date March 20, 2018
Actual Study Start Date April 30, 2016
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2018)
  • 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 ]
Original Primary Outcome Measures
 (submitted: September 2, 2016)
  • The incidence of 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 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension,
Condition Hypotension
Intervention
  • Drug: Cafedrine/theodrenaline
  • Drug: Ephedrine
Study Groups/Cohorts
  • Cohort A
    Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia
    Interventions:
    • Drug: Cafedrine/theodrenaline
    • Drug: Ephedrine
  • Cohort B
    Patients, who undergo caesarean section under spinal anaesthesia
    Interventions:
    • Drug: Cafedrine/theodrenaline
    • Drug: Ephedrine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 16, 2018)
2013
Original Estimated Enrollment
 (submitted: September 2, 2016)
1870
Actual Study Completion Date December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02893241
Other Study ID Numbers TV48531-CV-40092
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Teva Pharmaceutical Industries ( Ratiopharm GmbH )
Study Sponsor Ratiopharm GmbH
Collaborators Not Provided
Investigators
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
PRS Account Teva Pharmaceutical Industries
Verification Date March 2018