Primary objective:To compare the mean absolute glucose change in postoperative older patients with and without a delirium.Secondary objectives:1. To compare the mean glucose concentration and glucose variability in postoperative older patients with…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean absolute glucose change per hour (mmol/l/hour)
Secondary outcome
-The mean glucose concentration.
-Glucose variability: standard devation of the mean glucose concentration and
coefficient of variation and the mean glucose daily delta change
- The presence of an isolated hypoglycemia or hyperglycemia.
Potential risk factors:
1. Age 2. Gender 3. Body mass index 4. Cigarette smoking 5. Alcohol consumption
6. Introduction of diabetes mellituis treatment
7. Number of glucose influencing drugs. 8. Insulin concentration 9. Occurrence
of a delirium. 10.Treatment with antipsychotic drugs. 11. Occurrence of any
infection. 12. Nutrition. 13. Vitamin D concentration 14.Pain 15. Iron status
16. Serum triglycerides
17. Blood coagulation
- Length of hospital admission
- 6- months and 1 year mortality
Background summary
Delirium is frequently observed as a complication after surgery and associated
with high morbidity and mortality, especially in older patients. The effect of
a delirium on glucose and its variability is not clear. As glycemic variability
is suggested to be a risk factor for poor outcome, extending knowledge of
glucose metabolism in delirium is necessary.
Study objective
Primary objective:
To compare the mean absolute glucose change in postoperative older patients
with and without a delirium.
Secondary objectives:
1. To compare the mean glucose concentration and glucose variability in
postoperative older patients with and without a delirium.
2. To compare the incidence of hypo- and hyperglycemia in postoperative older
patients with and without a delirium.
3. To identify risk factors for changes in mean absolute glucose change in
postoperative older patients with a delirium.
4. To determine the association between the mean absolute glucose change and
functional and cognitive function, the length of hospital stay and mortality.
Study design
Monocenter, investigator initiated, observational, prospective cohort study.
Study burden and risks
This observational study has negligible risks and a minimal impact for
participating patients. This study has no intervention in patients treatment.
Integration of regular blood sampling and blood sampling for study purposes
will be attempted were possible. This study will extend our knowledge about
glucose metabolism in delirium
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 to the Geriatric trauma unit or to the department of Orthopaedics for hip surgery.
An increased risk for the development of delirium using the Tergooi questionaire based on the Safety Management System theme 'vulerable older patients'.
Inclusion within 24 hours after hospital admission.
The patient speaks either Dutch or English.
Patient must be able to give written informed consent.
Exclusion criteria
Patients presenting with a diminished capacity to consent at admission.
Patients with a diagnose of diabetes mellitus and/ or treated with oral antidiabetic drugs or insulin.
Patients who are fed with parenteral nutrition during their hospital stay.
Patients who are enrolled in a study with a medicinal product.
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 | NL47733.041.14 |