Use of Amiodarone in Atrial Fibrillation Associated With Severe Sepsis or Septic Shock

• Status: Terminated
• Trial end date: 2018-09-20
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Amiodarone

Criteria

Inclusion Criteria:

• New onset atrial fibrillation

• Severe sepsis or septic shock (defined by ≥2 systemic inflammatory response syndrome criteria + infection)

Exclusion Criteria:

• Age < 18 years

• History of atrial flutter

• History of atrial fibrillation

• QTc >500 msec at baseline

• 2nd or 3rd degree AV block

• Currently receiving anti-arrhythmic therapy

• Untreated thyroid dysfunction

• Acute or chronic hepatic failure

• Other indication for antiarrhythmic therapy

• Recent cardiac surgery in last 30 days

• Pregnancy