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NCT02668432 · ClinicalTrials.gov registry record · Phase 4
Use of Amiodarone in Atrial Fibrillation Associated With Severe Sepsis or Septic Shock
A Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Terminated
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT02668432 is a Phase 4 study that was terminated before completion, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 9 participants.
The verdict
NCT02668432, a Phase 4 study, was terminated before completion, sponsored by The University of Texas Health Science Center at San Antonio.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study 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.
Interventions
- DRUG Amiodarone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2016-05 |
| Est. Completion | 2018-09-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02668432
The ClinicalTrials.gov registry entry for NCT02668432 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Amiodarone is the first listed.
NCT02668432 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02668432 about?
NCT02668432 is a clinical study titled "Use of Amiodarone in Atrial Fibrillation Associated With Severe Sepsis or Septic Shock". 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 ...
What is the current status of trial NCT02668432?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2016-05. Estimated completion is 2018-09-20.
What interventions are being tested in trial NCT02668432?
The interventions under investigation include: Amiodarone (DRUG).
Who is sponsoring clinical trial NCT02668432?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
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