Modeling of Amiodarone Effect on Heart Rate Control in Critically Ill Patients With Atrial Tachyarrhythmias (AMIRA)

September 24, 2019 updated by: Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
Aims Amiodarone is the gold-standard medication to control heart rate in critically ill patients with atrial tachyarrhythmias (ATs); however, effective doses and covariates influencing its efficacy remain unknown. The investigators therefore performed pharmacodynamic modeling of heart rate reduction induced by amiodarone in these patients. Methods and Results This observational study included 80 consecutive severely ill patients receiving amiodarone to treat ATs. A total of 1348 time-heart rate observations with 361 amiodarone dose administrations were analyzed during a period of up to 6 days after hospital treatment initiation using a nonlinear mixed-effect model. Pretreatment with amiodarone before intensive care administration, paroxysmal versus persistent AT, catecholamine infusion, and fluid and magnesium loading were among the covariates assessed in the model. In case of paroxysmal AT in a patient not pretreated with amiodarone, a 300 mg intravenous loading dose combined with an 800 mg oral dose on the first day, followed by 800 mg/day orally for 4 days was effective in achieving a heart rate between 80 and 115 bpm within the first day, and to maintain it during the next 4 days. Corresponding doses were twice as high in patients with persistent AT. Use of intravenous magnesium (p\0.02) and fluid loading (p\0.02) was associated with an earlier and greater heart rate decrease, while use of dobutamine had an opposite influence (p\0.05). Conclusions In critically ill patients with AT, the dose of amiodarone required to control heart rate is influenced by the type of AT and by other easily measurable conditions which may allow better individualization of amiodarone dosing.

Study Overview

Status

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Completed

Conditions

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Observational

Enrollment (Actual)

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80

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Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients who had received at least one dose of amiodarone to treat or prevent AT during their hospitalization from January 2007 to April 2012 in the 18-bed medical ICU of a tertiary teaching hospital

Description

Inclusion Criteria:

  • critically ill patients who had received at least one dose of amiodarone to treat or prevent AT during their hospitalization in the ICU.

Exclusion Criteria:

  • Patients with paced rhythm or incomplete charts were excluded

Study Plan

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How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
severely ill patients receiving amiodarone for ATs
cohort study was conducted from January 2007 to April 2012 in the 18-bed medical ICU of a tertiary teaching hospital.Data were extracted from the files of 80 consecutive critically ill patients who had received at least one dose of amiodarone to treat or prevent atrial tachycardia during their hospitalization in the ICU.
Drug: Amiodarone
Data were extracted from the files of 80 consecutive critically ill patients who had received at least one dose of amiodarone to treat or prevent AT during their hospitalization in the ICU.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: HR at 1rst administration of cordarone and then 4 to 6 times a day after each dosing until day 6 or death or ICU discharge
HR was retrieved from patients ICU charts
HR at 1rst administration of cordarone and then 4 to 6 times a day after each dosing until day 6 or death or ICU discharge

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Groupe Hospitalier Pitie-Salpetriere

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General Publications

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Study Start (ACTUAL)

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January 1, 2007

Primary Completion (ACTUAL)

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April 1, 2012

Study Completion (ACTUAL)

Study Completion

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April 1, 2012

Study Registration Dates

First Submitted

First Submitted

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January 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

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January 22, 2018

First Posted (ACTUAL)

First Posted

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January 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

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September 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIC1421-17-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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