ArrhythmiaPhase 4atropinePEINCT00575523
Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
A Phase 4 study testing Atropine in people with Arrhythmia and Respiratory Arrest, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Respiratory Arrest
- What is being tested?
- Atropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2003to Jan 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation
Who cannot join
- contraindication for the administration of atropine like
- narrow angle glaucoma
- mechanic stenoses of the GI-tract
- clinically relevant prostatic hypertrophy
- paralytic ileus
- myasthenia gravis
Show all 12Show fewer
- severe cerebral sclerosis
- acute lung edema
- acute myocardial infarction
- cardiac insufficiency
- hyperthyroidism
- patients with contraindication to undergo percutaneous ethanol instillation
Trial locations and contacts
1 site in 1 country.
Austria1 site
Div. of Gastroenterology and Hepatology, Medical University of Vienna
Vienna, 1090
About this study
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.
- Conditions
- Arrhythmia, Respiratory Arrest
- Being tested
- Atropine, Placebo
- Keywords
- atropine, percutaneous ethanol instillation, hepatoma, bradycardia, arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac, Apnea, Carcinoma, Hepatocellular, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation.
PlaceboDrug
1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.
| Study group | Role | What they receive |
|---|---|---|
| 1: Atropine | Active comparator | Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation. Receives: Drug: Atropine |
| 2: Placebo | Placebo comparator | 1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dysrhythmias
Measured: during percutaneous ethanol instillation
Secondary outcomes (1)
Clinical complications
Measured: during percutaneous ethanol instillation and consecutive 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startOct 2003
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Arnulf Ferlitsch, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575523
- Sponsor's protocol ID
- atropinePEI
- Acronym
- atropinePEI
- Status last verified
- Jan 2008
- First submitted
- 17 Dec 2007
- Last updated
- 25 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15025681Arnulf 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.
PubMed 19018977
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
- ClinicalTrials.gov ID
- NCT00575523
- Acronym / sponsor ID
- atropinePEI / atropinePEI
- Conditions
- Arrhythmia, Respiratory Arrest
- Keywords
- atropine, percutaneous ethanol instillation, hepatoma, bradycardia, arrhythmia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2003
- Study completion
- Jan 2008 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Atropine | Active comparator | Drug: AtropineAtropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation. |
| 2: Placebo | Placebo comparator | Drug: Placebo1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation
Key exclusion criteria (12 listed)
- contraindication for the administration of atropine like
- narrow angle glaucoma
- mechanic stenoses of the GI-tract
- clinically relevant prostatic hypertrophy
- paralytic ileus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtropineAtropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation. | Drug | 1: Atropine |
| Placebo1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation. | Drug | 2: Placebo |
Primary outcome
Occurrence of dysrhythmias
Time frame: during percutaneous ethanol instillation
1 secondary outcome
Clinical complications
Time frame: during percutaneous ethanol instillation and consecutive 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2008.
- Background: PubMed 15025681Ferlitsch 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.
- Derived from this study: PubMed 19018977Arnulf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnulf Ferlitsch, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine in people with Arrhythmia and Respiratory Arrest, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of dysrhythmias (time frame: during percutaneous ethanol instillation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00575523, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2008.