OndansetronNCT01759420
Ondansetron and the QT Interval In Adult Emergency Department Patients
An observational study of Ondansetron, run by C.R.Darnall Army Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ondansetron
- What is being tested?
- Ondansetron
- Type of treatment
- Injection or infusion
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to May 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population is adult (>18 years old) emergency department patients who have been deemed appropriate to receive intravenous ondansetron.
Who may be able to join
- Age >18
- Patient to receive 4mg of intravenous ondansetron
Who cannot join
- Age <18
- known long QT syndrome
- received oral or intravenous ondansetron within 4 hours of enrollment
- co-administration of any known QT prolonging agents
- QTc on baseline of >450 ms for males and >470ms for females
- allergy or known hypersensitivity to ondansetron
Show all 14Show fewer
- altered mental status
- non-sinus rhythm on baseline EKG
- hypokalemia (as defined by the lower limit of normal for the reference laboratory)
- hypomagnesemia (as defined by the lower limit of normal for the reference laboratory)
- any presentation for chest pain with signs of ischemia on baseline EKG
- QRS duration > 120 msec
- bundle branch block (right or left)
- ventricular pre-excitation or signs of left ventricular hypertrophy with repolarization abnormalities
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carl R Darnall Army Medical Center
Fort Hood, Texas, 78544
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
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.
Read the detailed description
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.
- Conditions
- Ondansetron
- Being tested
- Ondansetron
- Keywords
- Ondansetron, QT interval, QTc, QT prolongation, Drug induced QT prolongation
- Medical subject headings
- Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
4mg of intravenous ondansetron
| Study group | Role | What they receive |
|---|---|---|
| IV Ondansetron | Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan. Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QTc Interval With Ondansetron Administration
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.
Measured: Baseline to 20 minutes
Secondary outcomes (1)
Number of Adverse Events
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.
Measured: 20 minutes to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OndansetronStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- C.R.Darnall Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Madigan Army Medical Center
- Responsible party
- Principal investigator, Peter Moffett MD, C.R.Darnall Army Medical Center
- Investigators
- Peter M Moffett, MD, Principal investigator, Carl R Darnall Army Medical Center Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759420
- Sponsor's protocol ID
- 375393
- Status last verified
- Jun 2014
- First submitted
- 29 Dec 2012
- Last updated
- 26 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron and the QT Interval In Adult Emergency Department Patients
- ClinicalTrials.gov ID
- NCT01759420
- Acronym / sponsor ID
- 375393
- Conditions
- Ondansetron
- Keywords
- Ondansetron, QT interval, QTc, QT prolongation, Drug induced QT prolongation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- C.R.Darnall Army Medical CenterUS federal agency
- Collaborators
- Madigan Army Medical Center
- Study start
- Dec 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Posted 26 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV Ondansetron | – | Drug: OndansetronAdult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is adult (>18 years old) emergency department patients who have been deemed appropriate to receive intravenous ondansetron.
Key inclusion criteria (2 listed)
- Age >18
- Patient to receive 4mg of intravenous ondansetron
Key exclusion criteria (14 listed)
- Age <18
- known long QT syndrome
- received oral or intravenous ondansetron within 4 hours of enrollment
- co-administration of any known QT prolonging agents
- QTc on baseline of >450 ms for males and >470ms for females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronAlso: Zofran4mg of intravenous ondansetron | Drug | IV Ondansetron |
Primary outcome
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.
1 secondary outcome
Number of Adverse Events
Time frame: 20 minutes to 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter M Moffett, MD principal investigator
Carl R Darnall Army Medical Center Department of Emergency Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ondansetron, run by C.R.Darnall Army Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QTc Interval With Ondansetron Administration (time frame: Baseline to 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.