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

Sponsor
Ratiopharm GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT02893241
Collaborator
(none)
2,013
Enrollment
75
Locations
20
Actual Duration (Months)
26.8
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase

Study Design

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 :
Apr 30, 2016
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Dec 31, 2017

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. The incidence of newly occurring HR ≥ 100 beats/min [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 [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

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Teva Investigational Site 133 Aachen Germany
2 Teva Investigational Site 122 Amberg Germany
3 Teva Investigational Site 106 Aue Germany
4 Teva Investigational Site 116 Augsburg Germany
5 Teva Investigational Site 165 Aurich Germany
6 Teva Investigational Site 110 Bad Hersfeld Germany
7 Teva Investigational Site 134 Bad Saarow Germany
8 Teva Investigational Site 174 Bad Soden Germany
9 Teva Investigational Site 142 Baden-Baden Germany
10 Teva Investigational Site 121 Brake Germany
11 Teva Investigational Site 154 Dillingen Germany
12 Teva Investigational Site 119 Dresden Germany
13 Teva Investigational Site 171 Düsseldorf Germany
14 Teva Investigational Site 111 Eichstätt Germany
15 Teva Investigational Site 107 Essen Germany
16 Teva Investigational Site 167 Flensburg Germany
17 Teva Investigational Site 141 Friedberg Germany
18 Teva Investigational Site 131 Fulda Germany
19 Teva Investigational Site 114 Gelnhausen Germany
20 Teva Investigational Site 158 Gelsenkirchen Germany
21 Teva Investigational Site 164 Gießen Germany
22 Teva Investigational Site 159 Greifswald Germany
23 Teva Investigational Site 149 Göppingen Germany
24 Teva Investigational Site 113 Hamburg Germany
25 Teva Investigational Site 163 Hamburg Germany
26 Teva Investigational Site 143 Hannover Germany
27 Teva Investigational Site 144 Hannover Germany
28 Teva Investigational Site 151 Hannover Germany
29 Teva Investigational Site 129 Heilbronn Germany
30 Teva Investigational Site 112 Herford Germany
31 Teva Investigational Site 160 Hildesheim Germany
32 Teva Investigational Site 132 Homburg Germany
33 Teva Investigational Site 168 Idar-Oberstein Germany
34 Teva Investigational Site 147 Jena Germany
35 Teva Investigational Site 123 Karlsruhe Germany
36 Teva Investigational Site 157 Kassel Germany
37 Teva Investigational Site 104 Kempen Germany
38 Teva Investigational Site 146 Köln Germany
39 Teva Investigational Site 117 Leipzig Germany
40 Teva Investigational Site 135 Leipzig Germany
41 Teva Investigational Site 118 Leverkusen Germany
42 Teva Investigational Site 102 Lingen Germany
43 Teva Investigational Site 109 Ludwigsburg Germany
44 Teva Investigational Site 139 Lüneburg Germany
45 Teva Investigational Site 101 Marburg Germany
46 Teva Investigational Site 155 Minden Germany
47 Teva Investigational Site 138 Mönchengladbach Germany
48 Teva Investigational Site 127 München Germany
49 Teva Investigational Site 130 Münster Germany
50 Teva Investigational Site 124 Neuruppin Germany
51 Teva Investigational Site 152 Nürnberg Germany
52 Teva Investigational Site 173 Nürnberg Germany
53 Teva Investigational Site 156 Oldenburg Germany
54 Teva Investigational Site 108 Pforzheim Germany
55 Teva Investigational Site 136 Pirmasens Germany
56 Teva Investigational Site 172 Prien am Chiemsee Germany
57 Teva Investigational Site 150 Rheine Germany
58 Teva Investigational Site 125 Rostock Germany
59 Teva Investigational Site 169 Saalfeld Germany
60 Teva Investigational Site 148 Schwalmstadt Germany
61 Teva Investigational Site 166 Schwerin Germany
62 Teva Investigational Site 126 Solingen Germany
63 Teva Investigational Site 128 Traunstein Germany
64 Teva Investigational Site 170 Trier Germany
65 Teva Investigational Site 175 Ulm Germany
66 Teva Investigational Site 162 Unna Germany
67 Teva Investigational Site 153 Velbert Germany
68 Teva Investigational Site 105 Warendorf Germany
69 Teva Investigational Site 115 Wesel Germany
70 Teva Investigational Site 140 Wetzlar Germany
71 Teva Investigational Site 120 Wiesbaden Germany
72 Teva Investigational Site 137 Worms Germany
73 Teva Investigational Site 103 Würzburg Germany
74 Teva Investigational Site 145 Zwiesel Germany
75 Teva Investigational Site 146 Zwiesel Germany

Sponsors and Collaborators

  • Ratiopharm GmbH

Investigators

  • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ratiopharm GmbH
ClinicalTrials.gov Identifier:
NCT02893241
Other Study ID Numbers:
  • TV48531-CV-40092
First Posted:
Sep 8, 2016
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Additional relevant MeSH terms:
Hypotension
Cafedrine
Theodrenaline
Ephedrine

Study Results

No Results Posted as of Nov 9, 2021