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NCT01759420 · ClinicalTrials.gov registry record
Ondansetron and the QT Interval In Adult Emergency Department Patients
A clinical trial, sponsored by C.R.Darnall Army Medical Center.
- Completed
- Registry status
- 28
- Enrollment target
NCT01759420: Completed study, sponsored by C.R.Darnall Army Medical Center.
NCT01759420 is a clinical trial that has completed, run by C.R.Darnall Army Medical Center. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01759420 has completed, sponsored by C.R.Darnall Army Medical Center.
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the use of the medication ondansetron (zofran) in the emergency department. There are studies of the ability of ondansetron to cause a prolongation in the QT interval (a certain measurement on an EKG) in anesthesia and cancer patients, but not on emergency department patients. This is an observational study where patients that are going to receive the anti-nausea medicine ondansetron in the emergency department will have an EKG performed every 2 minutes for 20 minutes to determine if the QT interval prolongs and returns to normal in that time period. Any serious outcomes will be reported. There is expected to be no adverse outcomes from this routinely used medication.
Primary Outcome
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.
Interventions
- DRUG Ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-05 |
What the finished NCT01759420 record still lists
NCT01759420 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Ondansetron is the first listed.
NCT01759420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01759420 about?
NCT01759420 is a clinical study titled "Ondansetron and the QT Interval In Adult Emergency Department Patients". The purpose of this study is to assess the use of the medication ondansetron (zofran) in the emergency department. There are studies of the ability of ondansetron to cause a prolongation in the QT interval (a certain measurement on an EKG) in anesthesia and cancer patients, but not on emergency depa...
What is the current status of trial NCT01759420?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2012-12. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01759420?
The interventions under investigation include: Ondansetron (DRUG).
Who is sponsoring clinical trial NCT01759420?
This trial is sponsored by C.R.Darnall Army Medical Center, which has 3 total clinical trials registered on ClinicalTrials.gov.
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