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Trial record 71 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

Ondansetron and the QT Interval In Adult Emergency Department Patients

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ClinicalTrials.gov Identifier: NCT01759420
Recruitment Status : Completed
First Posted : January 3, 2013
Results First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Collaborator:
Madigan Army Medical Center
Information provided by (Responsible Party):
Peter Moffett MD, C.R.Darnall Army Medical Center

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Ondansetron
Intervention Drug: Ondansetron
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Ondansetron
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Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.

Ondansetron: 4mg of intravenous ondansetron

Period Title: Overall Study
Started 28
Completed 22
Not Completed 6
Reason Not Completed
Screen failure             5
Inaccurate EKG machine readings             1
Arm/Group Title IV Ondansetron
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Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.

Ondansetron: 4mg of intravenous ondansetron

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
13
  59.1%
Male
9
  40.9%
1.Primary Outcome
Title Change in QTc Interval With Ondansetron Administration
Hide Description 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.
Time Frame Baseline to 20 minutes
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ondansetron
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Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.

Ondansetron: 4mg of intravenous ondansetron

Overall Number of Participants Analyzed 22
Mean (95% Confidence Interval)
Unit of Measure: mS
19.7
(14 to 25.5)
2.Secondary Outcome
Title Number of Adverse Events
Hide Description 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.
Time Frame 20 minutes to 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ondansetron
Hide Arm/Group Description:

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

Ondansetron: 4mg of intravenous ondansetron

Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
0
(0 to 12.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Ondansetron
Hide Arm/Group Description

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

Ondansetron: 4mg of intravenous ondansetron

All-Cause Mortality
IV Ondansetron
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IV Ondansetron
Affected / at Risk (%)
Total   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Ondansetron
Affected / at Risk (%)
Total   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Peter Moffett MD
Organization: Carl R Darnall Army Medical Center
Phone: 254-288-8302
Responsible Party: Peter Moffett MD, C.R.Darnall Army Medical Center
ClinicalTrials.gov Identifier: NCT01759420     History of Changes
Other Study ID Numbers: 375393
First Submitted: December 29, 2012
First Posted: January 3, 2013
Results First Submitted: May 23, 2014
Results First Posted: June 26, 2014
Last Update Posted: June 26, 2014