Drug Interactions With Risk of QT-prolongation in a Gener... | NCT02043912

Studies
Drug Interactions With Risk of QT-prolongation in a General Hospital

NCT02043912

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Jun 11, 2014Estimated

Enrollment

222Actual

Phase

Not provided

Conditions

QT-prolongation

Interventions

Haloperidol

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jan 21, 2014

First Submission Date that Met QC Criteria

Jan 21, 2014

First Posted Date

Jan 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2014

Last Update Posted Date

Jun 11, 2014Estimated

Name	Class
Agentschap voor Innovatie door Wetenschap en Technologie	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Study design: epidemiological point prevalence study

Target population: Patients with haloperidol treatment

The following aspects will be investigated:

The medication profiles will be checked for drug interactions with risk of QT-prolongation.
Clinical risk factors for developing QT-prolongation (gender, age, (history of) cardiovascular disease, comorbidity,...) and lab results will be collected.
Safety measurements (e.g. ECG) will be documented.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

222Actual

Label	Type	Description	Intervention Names
patients treated with haloperidol			Drug: Haloperidol

Name	Type	Description	Arm Group Labels	Other Names
Haloperidol	Drug		patients treated with haloperidol	Haldol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QTc-interval (corrected for heart rate)		maximum one year before inclusion / one week after inclusion

Secondary Outcomes

Measure	Description	Time Frame
number of drug interactions (with risk of QT-prolongation)		one week before/after inclusion

Other Outcomes

Measure	Description	Time Frame
number of patients with an ECG before or after the start of haloperidol		maximum one year before inclusion / one week after inclusion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

treatment with haloperidol (started in the hospital)

Exclusion Criteria:

age < 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eline Vandael, PhD-student	KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitair Ziekenhuis Leuven		Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D008133	Long QT Syndrome
D016171	Torsades de Pointes

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006220	Haloperidol

Ancestor Terms

ID	Term
D002090	Butyrophenones
D007659	Ketones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided