Ondansetron and the QT Interval In Adult Emergency Department Patients

NCT01759420 | Completed Results

• 1 other identifier: 375393
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ondansetron

Keywords

Ondansetron; QT interval; QTc; QT prolongation; Drug induced QT prolongation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 20 minutes

Secondary Outcomes (1)

• Number of Adverse Events

  20 minutes to 8 hours

Study Arms (1)

IV Ondansetron

Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.

Drug: Ondansetron

Interventions

Ondansetron DRUG

4mg of intravenous ondansetron

Also known as: Zofran

IV Ondansetron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• C.R.Darnall Army Medical Center: lead
• Madigan Army Medical Center: collaborator

Study Sites (2)

Carl R Darnall Army Medical Center

Fort Hood, Texas, 78544, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Long QT Syndrome

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Peter Moffett MD
• Organization: Carl R Darnall Army Medical Center

peter.m.moffett.mil@mail.mil

254-288-8302

Study Officials

• Peter M Moffett, MD

  Carl R Darnall Army Medical Center Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Department of Emergency Medicine

Study Record Dates

• First Submitted: December 29, 2012
• First Posted: January 3, 2013
• Study Start: December 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 26, 2014
• Results First Posted: June 26, 2014

Record last verified: 2014-06

Locations

US (2)