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

Sponsor
Groupe Hospitalier Pitie-Salpetriere (Other)
Overall Status
Completed
CT.gov ID
NCT03413150
Collaborator
(none)
80
63

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Modeling of Amiodarone Effect on Heart Rate Control in Critically Ill Patients With Atrial Tachyarrhythmias
Actual Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Heart Rate [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Groupe Hospitalier Pitie-Salpetriere

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Joe Elie Salem, MD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT03413150
Other Study ID Numbers:
  • CIC1421-17-13
First Posted:
Jan 29, 2018
Last Update Posted:
Sep 26, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2019