Ondansetron and the QT Interval In Adult Emergency Department Patients
|ClinicalTrials.gov Identifier: NCT01759420|
Recruitment Status : Completed
First Posted : January 3, 2013
Results First Posted : June 26, 2014
Last Update Posted : June 26, 2014
|Condition or disease||Intervention/treatment|
Intravenous ondansetron is routinely used in adult emergency department patients experiencing nausea or vomiting. The FDA has changed the drug label to warn of prolongation of the QT interval and required the manufacturer to perform additional studies. There are rare case reports of cardiac electrical toxicity to include QT prolongation, atrial fibrillation, severe bradycardia, ventricular tachycardia, supraventricular tachycardia, and the potential for Torsades de Pointes. All of the reported literature on ondansetron comes from post-operative patients, patients receiving chemotherapy, and healthy volunteers, but has never been assessed in the emergency department population. Adult emergency department patients that do not meet the exclusion criteria will be enrolled prior to receiving intravenous ondansetron. Administration of ondansetron will be at the discretion of the attending physician. A twelve-lead electrocardiogram (EKG) or 12-lead rhythm strip will be generated prior to drug administration, and every 2 minutes following drug administration for 20 minutes after administration. During the entire 20 minutes the patient will be on a cardiac monitor and if any of the defined adverse cardiac electrical events occur (non-sinus rhythm, severe bradycardia, sudden cardiac death) the patient will be treated using standard Advanced Cardiac Life Support methods and admitted for continued monitoring. The mean maximal QTc prolongation (as measured by the Bazett formula), as well as the rate of adverse cardiac events with 95% confidence intervals will be reported.
The global objective of this study is to determine if routine use of intravenous ondansetron in the emergency department is associated with cardiac risks. The primary objective is to determine the mean maximal prolongation in QTc interval from baseline as measured by the Bazett formula. The secondary objective is to determine the number of severe adverse cardiac electrical events (non-sinus rhythm, severe bradycardia, sudden cardiac death) associated with routine use of intravenous ondansetron in the adult emergency department patient.
|Study Type :||Observational|
|Actual Enrollment :||28 participants|
|Official Title:||Ondansetron and the QT Interval In Adult Emergency Department Patients|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.
4mg of intravenous ondansetron
Other Name: Zofran
- Change in QTc Interval With Ondansetron Administration [ Time Frame: Baseline to 20 minutes ]The primary objective is to determine the mean maximal prolongation in QTc interval from baseline as measured by the Bazett formula. A baseline EKG will be obtained and then after drug administration an EKG will be performed every 2 minutes until 20 minutes has passed. The mean maximal QTc change will be calculated.
- Number of Adverse Events [ Time Frame: 20 minutes to 8 hours ]The secondary objective is to determine the number of severe adverse cardiac electrical events (non-sinus rhythm, severe bradycardia, sudden cardiac death) associated with routine use of intravenous ondansetron in the adult emergency department patient. All of these outcomes will be recorded for each patient during the emergency department stay which could range from 20 minutes to several hours.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759420
|United States, Texas|
|Carl R Darnall Army Medical Center|
|Fort Hood, Texas, United States, 78544|
|United States, Washington|
|Madigan Army Medical Center|
|Tacoma, Washington, United States, 98431|
|Principal Investigator:||Peter M Moffett, MD||Carl R Darnall Army Medical Center Department of Emergency Medicine|