Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit

NCT01461733 | Completed Phase 4 Results

• 2 other identifiers: NA5936 Heart and StrokeOHREB Protocol # 2006430-01
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. Not all patients with AF will have unstable heart function but those who have rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no unstable heart function are two fold. Patients can be treated by controlling the heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be controlled by medication and the AF can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the AF with medication for patients who only have the rapid heart rate. The objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with AF who have a rapid heart rate without unstable heart function.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; amiodarone

Outcome Measures

Primary Outcomes (1)

• Conversion From Atrial Fibrillation to Sinus Rhythm

  Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.

  From randomization to conversion or ICU discharge up to 100 months.

Study Arms (2)

amiodarone

EXPERIMENTAL

standard dose amiodarone

Drug: amiodarone

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

amiodarone DRUG

standard dose amiodarone

Also known as: non applicable

amiodarone

Placebo DRUG

placebo delivered blinded

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• new onset afib

You may not qualify if:

• hemodynamically unstable

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Heart and Stroke Foundation of Ontario: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Salmaan Kanji
• Organization: The Ottawa Hospital Research Institute

skanji@toh.on.ca

613-737-8899

Study Officials

• Salmaan Kanji, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: October 28, 2011
• Study Start: July 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 15, 2014
• Results First Posted: September 15, 2014

Record last verified: 2014-09