The main objective of this study is to obtain insight in the nutrient and fluid intake and nutrient and biomarker concentrations in the blood of patients after an acute ischemic stroke during initial hospital care until 13 weeks after hospital…
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
ischemische beroerte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/outcome of the study:
- Nutrient and fluid intake over time
- Biomarkers of vitamin and mineral status over time
Secondary outcome
Other study parameters/outcome of the study (if applicable):
- Questionaires and biomarkers of malnutrition over time
Background summary
Stroke is described by a poor blood flow to the brain resulting in cell death
and as such stroke is a leading cause of mortality. Across European countries
incidence rates vary between 100-700 per 100,000 inhabitants. There are two
main types of stroke: an ischemic stroke causing a poor blood flow due to a
lack of blood flow with an incidence rate between 65-85% and hemorrhagic stroke
causing a poor blood flow due to bleeding. Stroke patients suffer from multiple
factors that may influence dietary intake. Hence, stroke is an important
contributor for the development or deterioration of malnutrition in the
patient. The incidence of malnutrition after stroke has been shown to range
from 6-62% depending on the population that has been studied. However, data on
nutritional status and specific deficiencies are limited in this patient group.
The goal of this study is to learn more about the nutritional status of
patients with an ischemic stroke, both with and without dysphagia, during
hospitalization immediately after stroke incidence and during rehabilitation in
the first months after hospital discharge.
Study objective
The main objective of this study is to obtain insight in the nutrient and fluid
intake and nutrient and biomarker concentrations in the blood of patients after
an acute ischemic stroke during initial hospital care until 13 weeks after
hospital admission
Study design
This is an observational, multi-centre, longitudinal study in 50 subjects with
an acute ischemic stroke.
Study burden and risks
For patients questionnaires will be administered and at home they have to
complete a 3-day dietary intake diary twice. In addition blood will be
collected 4 times.
Subjects should comply with the instructions not to donate blood during study
participation and to be fasted at the time of blood withdrawal (which means not
to eat and drink at least 7 hours before; drinking of water is allowed up to 1
hour before sampling).
Results of the study will provide insight in the nutritional status of the
subjects. This information will be very useful for future monitoring of stroke
patients and the possibility to provide additional nutritional advice or
supplements to prevent deficiencies.
The burden is considered minimal and in our opinion, the benefits of a
potential better nutritional status for future patients outweigh the burden of
this study.
In addition, blood parameters will be analysed after the end of the study.
Results will be shared with the study team in the hospital and reviewed by a
physician on clinical relevance. In case of clinically relevant deviations the
subject and his/her General Practitioner will be informed of this.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
Subjects with an acute ischemic stroke (with and without dysphagia):
- Age * 50
- Diagnosis of ischemic stroke
- Included for participation in the study within 24h after admission.
Exclusion criteria
Subjects with an acute ischemic stroke (with and without dysphagia):
- History of progressive neurological disorders (e.g. Parkinson*s disease,
dementia, multiple sclerosis).
- Receiving any cancer treatment within 1 year before entry into the study
(signing of informed consent).
- Blood donation or receiving blood transfusion within 4 weeks before entry
into the study (informed consent) and/or planned blood donation during the study
- Traumatic brain injury
- Diagnosis of haemorrhagic stroke (subarachnoid or intracerebral) or transient
ischemic attack at hospital admission
- Any medical condition that significantly interferes with digestion and/or
gastrointestinal (GI) function except for dysphagia (e.g. short bowel syndrome,
inflammatory bowel disease, gastric ulcer, gastritis (gastro)enteritis, GI
cancer) as judged by the investigator.
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 | NL59614.068.17 |