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NCT Number: NCT02893241

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

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Teva Investigational Site 133, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cafedrine/theodrenaline

Drug

Ephedrine

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ratiopharm GmbH

Industry

Registry information

Official study title

Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting: a Multicenter, Prospective, Non-interventional Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2016
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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