NCT02043912

Brief Summary

In this epidemiological point prevalence study, medication profiles of patients with haloperidol treatment will be checked for drug interactions with risk of QT-prolongation. Additional clinical risk factors for developing QT-prolongation and safety measurements will be documented.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 11, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

January 21, 2014

Last Update Submit

June 10, 2014

Conditions

QT-prolongation

Keywords

QT-prolongationTorsade de PointesHaloperidolDrug interactions

Outcome Measures

Primary Outcomes (1)

  • QTc-interval (corrected for heart rate)

    maximum one year before inclusion / one week after inclusion

Secondary Outcomes (1)

  • number of drug interactions (with risk of QT-prolongation)

    one week before/after inclusion

Other Outcomes (1)

  • number of patients with an ECG before or after the start of haloperidol

    maximum one year before inclusion / one week after inclusion

Study Arms (1)

patients treated with haloperidol

Drug: Haloperidol

Interventions

HaloperidolDRUG
Also known as: Haldol
patients treated with haloperidol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who are treated with haloperidol (every tuesday we will make a selection of the patients who received haloperidol on monday)

You may qualify if:

  • treatment with haloperidol (started in the hospital)

You may not qualify if:

  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Long QT SyndromeTorsades de Pointes

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardia, VentricularTachycardia

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Eline Vandael, PhD-student

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-student

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 23, 2014

Study Start

July 1, 2013

Primary Completion

February 1, 2014

Study Completion

April 1, 2014

Last Updated

June 11, 2014

Record last verified: 2014-06

Locations

BE(1)