Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital

NCT02068170 | Completed

• 1 other identifier: EV003
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, observational study in a university hospital (UZ Leuven). Patients are included when they are treated with a potentional QT-prolonging drug: haloperidol for delirium, antibiotics (moxifloxacin, levofloxacin, azithromycin, clarithromycin, erythromycin, co-trimoxazole), antimycotics (ketoconazole, itraconazole, fluconazole, voriconazole), methadone, tacrolimus and oral oncolytics. An ECG is taken before the administration of the drug and 3-5 days after starting the drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation will be documented. Together with ECG2, an additional blood sample will be collected to measure the blood concentration of the drug.

Conditions

Delirium; QT-prolongation

Keywords

QT-prolongation; Torsade de Pointes; QT-prolonging drugs

Outcome Measures

Primary Outcomes (1)

• change in QTc-interval (corrected for heart rate)

  before and 3-5 days after the start of a potentional QT-prolonging drug

Study Arms (1)

patients treated with a potentional QT-prolonging drug

Drug: Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib

Interventions

Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib DRUG

Also known as: haloperidol: Haldol, ATC-code: N05AD01, azithromycin: Zitromax, ATC-code: J01FA10, clarithromycin: Biclar, ATC-code: J01FA09, erythromycin: Erytroforte, ATC-code: J01FA01, levofloxacin: Tavanic, ATC-code: J01MA12, moxifloxacin: Avelox, ATC-code: J01MA14, co-trimoxazole: Bactrim, Eusaprim, ATC-code: J01EE01, voriconazole: Vfend, ATC-code: J02AC03, ketoconazole: Nizoral, ATC-code: J02AB02, fluconazole: Diflucan, ATC-code: J02AC01, itraconazole: Sporanox, ATC-code: J02AC02, methadone: ATC-code: N07BC02, tacrolimus: Prograft, Advagraft, ATC-code: L04AD02, sunitinib: Sutent, ATC-code: L01XE04

patients treated with a potentional QT-prolonging drug

Eligibility Criteria

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

Study Population

Patients treated with acute potentional QT-prolonging medication. In a university hospital.

You may qualify if:

• treatment with a potentional QT-prolonging drug of our list
• inpatient of UZ Leuven, admitted on one of the participating wards

You may not qualify if:

• \< 18 years old
• DNR-code 3
• not possible to take an ECG before the start of haloperidol

Sponsors & Collaborators

• KU Leuven: lead
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Vandael E, Vandenberk B, Vandenberghe J, Spriet I, Willems R, Foulon V. Development of a risk score for QTc-prolongation: the RISQ-PATH study. Int J Clin Pharm. 2017 Apr;39(2):424-432. doi: 10.1007/s11096-017-0446-2. Epub 2017 Mar 9.

  PMID: 28281228 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* 1 blood sample (plasma) to measure the blood concentration of the drug * 1 blood sample (DNA) to store in a biobank for additional research

MeSH Terms

Conditions

Delirium; Long QT Syndrome; Torsades de Pointes

Interventions

Haloperidol; Erythromycin; Trimethoprim, Sulfamethoxazole Drug Combination; Methadone; Tacrolimus; Sunitinib

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; 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; Tachycardia, Ventricular; Tachycardia

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Macrolides; Polyketides; Lactones; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Pyrroles; Azoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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: February 18, 2014
• First Posted: February 21, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

BE (1)