Trial Outcomes & Findings for Ondansetron and the QT Interval In Adult Emergency Department Patients (NCT NCT01759420)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

Baseline to 20 minutes

Results posted on

2014-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	IV Ondansetron Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan. Ondansetron: 4mg of intravenous ondansetron
Overall Study STARTED	28
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	IV Ondansetron Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan. Ondansetron: 4mg of intravenous ondansetron
Overall Study Screen failure	5
Overall Study Inaccurate EKG machine readings	1

Baseline Characteristics

Ondansetron and the QT Interval In Adult Emergency Department Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Ondansetron n=22 Participants Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan. Ondansetron: 4mg of intravenous ondansetron
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	IV Ondansetron n=22 Participants Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan. Ondansetron: 4mg of intravenous ondansetron
Change in QTc Interval With Ondansetron Administration	19.7 mS Interval 14.0 to 25.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	IV Ondansetron n=23 Participants Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan. Ondansetron: 4mg of intravenous ondansetron
Number of Adverse Events	0 percentage of patients Interval 0.0 to 12.5

Adverse Events

IV Ondansetron

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Moffett MD

Carl R Darnall Army Medical Center

Phone: 254-288-8302

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place