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

Completed

• Conditions: Hypotension
• Interventions: Drug: Cafedrine/theodrenaline; Drug: Ephedrine

• Registration Number: NCT02893241
• Lead Sponsor: Ratiopharm GmbH

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 available

Study Timeline

• Study Start: 2016-04-30
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-08
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2013

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	Cafedrine/theodrenaline	Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia
Cohort A	Ephedrine	Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia
Cohort B	Ephedrine	Patients, who undergo caesarean section under spinal anaesthesia
Cohort B	Cafedrine/theodrenaline	Patients, who undergo caesarean section under spinal anaesthesia

Primary Outcome Measures

Name	Time	Method
The incidence of newly occurring HR ≥ 100 beats/min	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	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

Trial Locations

Locations (74)

Teva Investigational Site 133; 🇩🇪 Aachen, Germany

Teva Investigational Site 122; 🇩🇪 Amberg, Germany

Teva Investigational Site 106; 🇩🇪 Aue, Germany

Teva Investigational Site 116; 🇩🇪 Augsburg, Germany

Teva Investigational Site 165; 🇩🇪 Aurich, Germany

Teva Investigational Site 110; 🇩🇪 Bad Hersfeld, Germany

Teva Investigational Site 134; 🇩🇪 Bad Saarow, Germany

Teva Investigational Site 174; 🇩🇪 Bad Soden, Germany

Teva Investigational Site 142; 🇩🇪 Baden-Baden, Germany

Teva Investigational Site 121; 🇩🇪 Brake, Germany

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