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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2017

Interventions

  • Drug: Cafedrine/theodrenaline
  • Drug: Ephedrine

Arms, Groups and Cohorts

  • Cohort A
    • Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia
  • Cohort B
    • Patients, who undergo caesarean section under spinal anaesthesia

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ratiopharm GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Teva Medical Expert, MD, Study Director, Teva Branded Pharmaceutical Products R&D, Inc.

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