To study the relationship between (a) abnormal concentrations of plasma amino-acids, pterins, HVA and inflammatory parameters and (b) the severity, duration and outcome of delirium. To find a biochemical profile that predicts the occurrence of a…
ID
Source
Brief title
Condition
- Ancillary infectious topics
- Deliria (incl confusion)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: The severity and clinical outcome of the delirium in relation to the
biochemical parameters. The end of delirium is defined as the resolution of
delirium symptoms on the DOS scale.
Secondary outcome
Secundary:
1 DRS-R-98 scale (severity delirium) and MMSE score at the assessment moments.
2 The concentration of HVA and neopterin in plasma.
3 The concentration of interleukine-6 and CRP in the serum.
Background summary
Delirium is a complex neuropsychiatric syndrome with an acute onset and
fluctuating course. Prevalence figures for medical inpatients range from
10-60%. Older patients with a delirium are at significant risk of
complications, prolonged hospital admission, institutionalisation and death.
Treatment is based on treating the underlying cause -usually a chest or urinary
tract infection-. Treatment of the neuropsychiatric symptoms is symptomatic,
and consists of antipsychotics and benzodiazepines.
Several studies have suggested the presence of disturbed cholinergic,
dopaminergic and serotonergic pathways in delirium. Especially, a disturbed
metabolism of the amino-acid tryptophan has been found, as well as an increase
in the metabolite of dopamine, homovanillic acid (HVA). Evidence exists that a
cytokine response is present, especially of interleukin (IL)-6. Also, there is
an increase in C-reactive protein [CRP] and in the oxidative stress marker
neopterin.
Despite an increased awareness of the importance of the early recognition and
treatment of delirium, figures for complete recovery are poor. Mortality is
high and many patients do not return to their previous level of functioning.
Our hypothesis is that the levels of neopterin, HVA, and inflammatory
parameters can be of prognostic value in the diagnosis, treatment and outcome
of delirium. The current study is proposed to investigate this issue.
Study objective
To study the relationship between (a) abnormal concentrations of plasma
amino-acids, pterins, HVA and inflammatory parameters and (b) the severity,
duration and outcome of delirium. To find a biochemical profile that predicts
the occurrence of a delirium during the stay in the rehabilitation ward.
Study design
An open controlled study in patients diagnosed with a delirium during or at
admission to the rehabilitation wards. The diagnosis delirium is based on the
DSM-IV criteria. Observation of delirium will be performed using the Delirium
Observation Screening Scale (DOS-scale). To determine the severity of delirium
a Delirium Rating Scale (DRS-R-98) will be used. Whether or not the delirium is
caused by infection will be recorded. Every patient will undergo an MMSE and
blood tests.
Study burden and risks
Two extra venous blood samples will need to be taken, these will be combined as
much as possible with taking of blood samples for the regular treatment.
's Gravendijkwal 230
3015CE Rotterdam
Nederland
's Gravendijkwal 230
3015CE Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
·Age 65 years or older
·Admitted to the rehabilitation ward of Verpleeghuis Laurens Antonius Binnenweg, Rotterdam.
·Diagnosis of delirium made at or during admission (DSM IV 293.0).
·Informed consent to participate in the study, signed by the patient or the legal representative.
-Consent tot participate can also be given at the end of the study (if consent is not given, the CRF will be deleted).
Exclusion criteria
·Diagnosed with a severe, instable medical condition other than the reason for admission
·Contra-indication for the use of haloperidol
·Known neuroleptic malignant syndrome
·Tardive dyskinesia
·Lewy-body dementia
·Ongoing treatment with an antipsychotic other than haloperidol
·Severe dementia defined as an MMSE-score of <11/30 points in patients without a delirium at inclusion
·Unable to speak and/or understand dutch
·Admission shorter than 5 days
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 | NL18154.078.07 |