Use of Amiodarone in Atrial Fibrillation Associated With Severe Sepsis or Septic Shock
Status:
Terminated
Trial end date:
2018-09-20
Target enrollment:
Participant gender:
Summary
Purpose/Objectives: Severe sepsis and septic shock are a common cause of new onset atrial
fibrillation (NOAF) in the intensive care unit. Development of NOAF in this setting can
prolong length of stay and increase mortality. Amiodarone is the most commonly used agent
used in this setting to control rate and rhythm. However, limited data exist detailing
appropriate dosing in this setting. The primary objective of this study is to evaluate two
amiodarone dosing strategies, a full loading dose versus a partial loading dose, in patients
with new-onset atrial fibrillation (AF) due to severe sepsis or septic shock to assess the
mean heart rate every 6 hours after initiation of amiodarone infusion to day 7 or death.
Research Design/Plan: Consecutive patients admitted to the medical or cardiac intensive care
unit at University Hospital with NOAF in the setting of severe sepsis or septic shock will be
screened for study inclusion. Data will be collected and stored using Microsoft Excel or
Access and analyzed with JMP 12.0 and SPSS.
Methods: Patients aged 18 years or older who develop new-onset atrial fibrillation in the
setting of severe sepsis or septic shock and in whom the medical team deems appropriate to
initiate amiodarone therapy in will be considered for study inclusion. Patients will receive
intravenous (IV) and oral (PO) amiodarone, as per the standard of care. Patients will be
randomized to a certain quantitative loading dose strategy; either a full loading dose (≥ 5g
IV or ≥10g PO +/- 20%) or a partial loading dose (<4g IV or < 8g PO).
Clinical Relevance: With intensive care unit length of stay (ICU LOS) and mortality being
twice as high in NOAF with sepsis as compared to septic patients without NOAF, the
investigators ultimately aim to identify a management strategy that may minimize this
morbidity and mortality while also minimizing exposure to a drug that may cause serious
adverse effects.
Phase:
Phase 4
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio