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Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy (atropinePEI)

Primary Purpose

Arrhythmia, Respiratory Arrest

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Atropine
Placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrhythmia focused on measuring atropine, percutaneous ethanol instillation, hepatoma, bradycardia, arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation

Exclusion Criteria:

  • contraindication for the administration of atropine like
  • narrow angle glaucoma
  • mechanic stenoses of the GI-tract
  • clinically relevant prostatic hypertrophy
  • paralytic ileus
  • myasthenia gravis
  • severe cerebral sclerosis
  • acute lung edema
  • acute myocardial infarction
  • cardiac insufficiency
  • hyperthyroidism
  • patients with contraindication to undergo percutaneous ethanol instillation

Sites / Locations

  • Div. of Gastroenterology and Hepatology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1: Atropine

2: Placebo

Arm Description

Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation.

1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.

Outcomes

Primary Outcome Measures

Occurrence of dysrhythmias

Secondary Outcome Measures

Clinical complications

Full Information

First Posted
December 17, 2007
Last Updated
January 23, 2008
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00575523
Brief Title
Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
Acronym
atropinePEI
Official Title
Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ultrasound guided percutaneous ethanol injection (PEI) is an established method in the treatment of hepatocellular carcinoma (HCC) and considered a safe procedure with severe complications occurring rarely. Previous studies revealed, that the occurrence of bradycardia and sinuatrial blockage is quite frequent during ethanol instillation sometimes accompanied by clinical complications such as unconsciousness, respiratory arrest or seizure like symptoms. Study purpose is to evaluate whether the use of i.v. Atropine before starting ethanol instillation can prevent dysrhythmias during instillation. Study design: randomized, placebo controlled, double blinded study. Atropine or saline solution will be administered intravenously to 40 patients immediately before starting percutaneous ethanol instillation. A 6 line ECG with limb leads will be recorded at rest and during ethanol instillation to reveal possibly occurring dysrhythmias.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia, Respiratory Arrest
Keywords
atropine, percutaneous ethanol instillation, hepatoma, bradycardia, arrhythmia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Atropine
Arm Type
Active Comparator
Arm Description
Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation.
Arm Title
2: Placebo
Arm Type
Placebo Comparator
Arm Description
1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Description
Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.
Primary Outcome Measure Information:
Title
Occurrence of dysrhythmias
Time Frame
during percutaneous ethanol instillation
Secondary Outcome Measure Information:
Title
Clinical complications
Time Frame
during percutaneous ethanol instillation and consecutive 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation Exclusion Criteria: contraindication for the administration of atropine like narrow angle glaucoma mechanic stenoses of the GI-tract clinically relevant prostatic hypertrophy paralytic ileus myasthenia gravis severe cerebral sclerosis acute lung edema acute myocardial infarction cardiac insufficiency hyperthyroidism patients with contraindication to undergo percutaneous ethanol instillation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnulf Ferlitsch, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Div. of Gastroenterology and Hepatology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
15025681
Citation
Ferlitsch A, Kreil A, Bauer E, Schmidinger H, Schillinger M, Gangl A, Peck-Radosavljevic M. Bradycardia and sinus arrest during percutaneous ethanol injection therapy for hepatocellular carcinoma. Eur J Clin Invest. 2004 Mar;34(3):218-23. doi: 10.1111/j.1365-2362.2004.01321.x.
Results Reference
background
PubMed Identifier
19018977
Citation
Arnulf F, Monika S, Herwig S, Monika H, Johannes PD, Gregor U, Alfred G, Markus PR. Atropine for prevention of cardiac dysrhythmias in patients with hepatocellular carcinoma undergoing percutaneous ethanol instillation: a randomized, placebo-controlled, double-blind trial. Liver Int. 2009 May;29(5):715-20. doi: 10.1111/j.1478-3231.2008.01905.x. Epub 2008 Oct 27.
Results Reference
derived

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Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy

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