Primary objective 1. To examine the association between the use of haloperidol and the acute changes in fastening serum glucose and QT interval in elderly patients undergoing surgery. Secondary objectives 1.To examine the association between the use…
ID
Source
Brief title
Condition
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a. Serum level of fastening glucose (mmol/l). b. QT interval measured by
(holter) ECG using Fridericia*s formula .
Secondary outcome
1. Serum level of triglycerides (mmol/l). 2. Closure time (sec), measured by
Platelet Functional Analyser (PFA-100). 3. Serum concentration haloperidol (µg/
L). 4. Daily defined dose, total antipsychotic exposure in haloperidol users.
5. Genetic polymorphisms at D2 receptor, serotonin 2c receptor,
methylenetetrahydrofolate reductase (MTHFR), NUBPL and NOS1AP genes.
Background summary
It is difficult to extrapolate results of studies investigating metabolic
adverse effects of antipsychotic drugs in the younger population to the elderly
population, because of possible differences in indication for treatment,
comorbidity and polypharmacy. Elderly are more sensitive to antipsychotic drugs
through age related changes in peripheral and central pharmacokinetics and
pharmacodynamics, resulting in different dose regimes. And age- associated
changes in body composition, increased fat mass and decreased muscle mass
enhance insulin resistance, which is related to an increased prevalence of
metabolic syndrome in the elderly. Not all patients experience antipsychotic
induced metabolic effects to the same extent. Available literature on
antipsychotic induced cardiometabolic effects in elderly people is scarce,
awareness of possible metabolic adverse effects in elderly is lacking in daily
clinical practice and it is unclear if more effort is needed to improve
monitoring of cardiometabolic risk factors in elderly patients. The aim of this
study is to extend our knowledge of the acute cardiometabolic adverse effects
of haloperidol treatment in elderly patients, focussing on changes in fastening
serum glucose and QT interval.
Study objective
Primary objective 1. To examine the association between the use of haloperidol
and the acute changes in fastening serum glucose and QT interval in elderly
patients undergoing surgery. Secondary objectives 1.To examine the association
between the use of haloperidol and acute changes in triglycerides in elderly
patients undergoing surgery. 2.To examine the association between the use of
haloperidol and acute changes in platelet aggregation in elderly patients
undergoing surgery. 3.To analyse the relation between dosage and concentration
of haloperidol and changes in fastening serum glucose and QT interval in
elderly patients. 4.To evaluate differences in DNA profile in patients with and
without changes in fastening serum glucose and QT interval using haloperidol.
Study design
Prospective, observational study to examine acute changes in cardiometabolic
parameters and platelet aggregation in elderly patients using haloperidol
compared to elderly without using haloperidol.
Study burden and risks
This observational study has negligible risks and a minimal impact for
participating patients. Integration of regular blood sampling and blood
sampling for study purposes will be attempted.
Van Riebeeckweg 212
Hilversum 1213 XZ
NL
Van Riebeeckweg 212
Hilversum 1213 XZ
NL
Listed location countries
Age
Inclusion criteria
Age 70 years or older.
Admitted for a hip fracture or other fall- related fracture on the department of Surgery or Orthopaedics.
Inclusion within 24 hours after admission on the department.
The patient or representative speaks either Dutch or English.
Patient or representative must be able to give informed consent
Exclusion criteria
Use of an antipsychotic agent within 90 days before hospital admission.
Patient is not undergoing surgery for the hip fracture or other fall- related fracture.
Start or dose changes in the following medication in the 14 days before admission:
Thrombocyte aggregation inhibitors
QT- prolongating drugs
Antidiabetic drugs
Antihypertensive drugs
Cholesterol- lowering drugs
Additional for recording a holter electrocardiogram (ECG) for patients in subgroup 1:
History of pacemaker implantation, atrial fibrillation, bundle branch block, congenital QT- syndrome.
Use of QT prolongating drugs (CERT list 1 www.azcert.org) in the 14 days before admission.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | na goedkeuring METC zal aanmelding plaatsvinden. |
| CCMO | NL44683.041.13 |