Suspended

The Effect of Intravenous vs. Oral Administration of Amiodarone on the Incidence Rate of Phlebitis Among Patients With Recent Onset of Atrial Fibrillation (AF)

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What is being tested

Amiodarone

+ Amiodarone

Drug
Who is being recruted

Arrhythmias, Cardiac+11

+ Cardiovascular Diseases

+ Heart Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorWestern Galilee Hospital-Nahariya
Study ContactLilach Shema-didi, PhDMore contacts
Last updated: March 25, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

Atrial fibrillation (AF) is the most common heart rhythm abnormality worldwide. Three therapeutic goals should be considered for each patient: Rate control, maintenance of sinus rhythm and prevention of thromboembolism. In managing AF, numerous antiarrhythmic drugs have been used. Intravenous amiodarone is a class III antiarrhythmic agent which has been reported to be safe and most effective in various clinical settings, without an associated increase in mortality rate. In most of the cases, the method of administration is via peripheral infusion. Phlebitis is the most common complication with peripheral infusion of amiodarone. Phlebitis adversely affects patient care; it may interfere with the continued infusion of amiodarone, necessitate insertion of another peripheral intravenous or central catheter, and extend hospitalization. Furthermore, patients who develop phlebitis, experience pain, swelling, and inflammation. Phlebitis can be prevented by oral administration. The goal of the proposed study is to evaluate the incidence rate of phlebitis following IV administration of amiodarone and to investigate whether the oral administration of amiodarone in patients with recent onset AF (duration < 48 h), is safer than, and as efficient as, the IV administration of the same drug in the ICCU and ICU setting.

Principal SponsorWestern Galilee Hospital-Nahariya
Study ContactLilach Shema-didi, PhDMore contacts
Last updated: March 25, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

104 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsThrombosisVascular DiseasesVasculitisPeripheral Vascular DiseasesEmbolism and ThrombosisVenous ThrombosisAtrial FibrillationPhlebitisThrombophlebitis

Criteria

3 inclusion criteria required to participate
Over 18 years of age

Patients who will be admitted to the ICCU / ICU wards

Patients with recent onset of atrial fibrillation (duration < 48h)

7 exclusion criteria prevent from participating
Age < 18 years

Baseline systolic blood pressure < 100 mm/hg

Known thyroid disease

Participation in other clinical trial

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
oral amiodarone 400 mg three times a day for 2 days

Group II

Experimental
Amiodarone: IV loading of 300 mg for 30 min in 100cc glucose 5% IV infusion with 900 mg/24h in 1000cc glucose 5%

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Western Galilee Hospital

Nahariya, IsraelOpen Western Galilee Hospital in Google Maps
SuspendedOne Study Center