To investigate whether peak melatonin level and daily secretion patterns differ between delirious and non-delirious older persons admitted to the ICU. To determine factors that potentially influence the association between delirium and melatonin…
ID
Source
Brief title
Condition
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be the differences in the maximal concentration of
melatonin in critically ill elderly with or without delirium during ICU
admission.
Secondary outcome
Secondary outcomes will be the (differences in) melatonin secretion pattern,
defined as the percentage peak melatonin concentration that are secreted
between 23pm and 6am, in older persons with and without delirium for seven
consecutive days.
Also, we will study if sepsis, mechanical ventilation, renal failure or (nor)
adrenergic stimulation influence melatonin secretion patterns in patients
admitted to the ICU.
Background summary
Delirium is a common problem in elderly persons admitted to the ICU. Earlier
studies observed an altered secretion pattern and low plasma concentration of
melatonin in delirious ICU patients, suggesting that disturbances in the
circadian rhythm could be a possible cause for the development of delirium.
However, these earlier studies were in small groups and in varying conditions,
with contradicting results. The aim of this proposal is to investigate in a
larger cohort whether melatonin peak concentrations and secretion patterns
differ between delirious and non-delirious elderly patients during ICU
admission. Because much is still unknown about the aetiology of delirium, this
would contribute to our body of knowledge.
Study objective
To investigate whether peak melatonin level and daily secretion patterns differ
between delirious and non-delirious older persons admitted to the ICU. To
determine factors that potentially influence the association between delirium
and melatonin levels.
Study design
Case-comparison prospective, multi-centre, observational study.
Study burden and risks
Waste material of daily blood samples taken for clinical reasons will be
analysed. If there is no blood sample taken for clinical reasons around 3am,
6am, 3pm and 11pm, a blood sample of 2ml will be collected via an, -already
present-, arterial or venous catheter in order to minimize eventual burden. We
aim to obtain 4 samples a day, of which we estimate a maximum of 2 samples will
have to be collected just for study purposes. Approximately 2 millilitres of
blood is needed to measure the melatonin concentration. Blood samples will be
collected until ICU discharge or for a maximum of 7 consecutive days. We
estimate that we will have to collect maximal 28 ml of blood just for study
purposes.The risks in this study are associated with collecting blood samples,
and these are considered to be very low.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Age 60 years or above
- Patients or their legal representative must be able to give informed consent
- Inclusion directly after ICU admission, but at least within 24 hours of admission
- Expected admission to the ICU for longer than one day
- Medical or surgical reason for admission to the ICU
Exclusion criteria
- Stroke as the reason for hospital admission
- Chronic use of antidepressants or antipsychotics before ICU admission
- Use of melatonin before or during hospital admission
- Dialysis before admission
- History of diagnosed dementia
- Absence of arterial or central venous catheter
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 |
|---|---|
| CCMO | NL47935.018.14 |