Ondansetron and the QT Interval In Adult Emergency Department Patients

This study has been completed.
Sponsor:
Collaborator:
Madigan Army Medical Center
Information provided by (Responsible Party):
Peter Moffett MD, C.R.Darnall Army Medical Center
ClinicalTrials.gov Identifier:
NCT01759420
First received: December 29, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Ondansetron
Drug: Ondansetron

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ondansetron and the QT Interval In Adult Emergency Department Patients

Resource links provided by NLM:


Further study details as provided by C.R.Darnall Army Medical Center:

Primary Outcome Measures:
  • Change in QTc Interval With Ondansetron Administration [ Time Frame: Baseline to 20 minutes ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 20 minutes to 8 hours ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 28
Study Start Date: December 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IV Ondansetron
Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.
Drug: Ondansetron
4mg of intravenous ondansetron
Other Name: Zofran

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The target population is adult (>18 years old) emergency department patients who have been deemed appropriate to receive intravenous ondansetron.

Criteria

Inclusion Criteria:

  • Age >18
  • Patient to receive 4mg of intravenous ondansetron

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759420

Locations
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
Sponsors and Collaborators
C.R.Darnall Army Medical Center
Madigan Army Medical Center
Investigators
Principal Investigator: Peter M Moffett, MD Carl R Darnall Army Medical Center Department of Emergency Medicine
  More Information

No publications provided

Responsible Party: Peter Moffett MD, Director of Research, Department of Emergency Medicine, C.R.Darnall Army Medical Center
ClinicalTrials.gov Identifier: NCT01759420     History of Changes
Other Study ID Numbers: 375393
Study First Received: December 29, 2012
Results First Received: May 23, 2014
Last Updated: June 24, 2014
Health Authority: United States: Federal Government

Keywords provided by C.R.Darnall Army Medical Center:
Ondansetron
QT interval
QTc
QT prolongation
Drug induced QT prolongation

Additional relevant MeSH terms:
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on October 01, 2014