Post-Stroke Delirium
Conditions
Brief summary
The main goal of this study is to identify indwelling urinary catheterization (IUC) as a predictive factor of the development of delirium in male acute stroke patients.
Detailed description
The main goal of this study is to identify indwelling urinary catheterization (IUC) as a predictive factor of the development of delirium in male acute stroke patients. With a prospective randomized-controlled interventional study design it aims to provide reliable evidence to effectively reduce delirium as well as secondary complications after IUC in critically ill patients. Until now, male, severely affected acute stroke patients regularly receive IUC for recanalization therapy or to balance fluid intake. Complications might be urinary infections, agitation and accidental removal by the patient himself with urinary bleeding. We ought to investigate if early removal of the IUC after recanalization therapy and replacement with either a condom catheter or a diaper might reduce complications after catheterization and hereby reduce delirium. As a secondary outcome we would like to explore other options besides indwelling urinary catheterization for balancing the fluid in- and output.
Interventions
DEVICEcondom catheter
The subjects will be randomly assigned to one of two groups. The subjects in the control group will receive as part of our ongoing clinical routine an IUC at the time of admission. For IUC a well established standard operating procedure in our clinic will be followed (https://vswroxtra01.ukt.ad.local/Roxtra/index.aspx: Legen eines transurethralen Blasenkatheters (BLK). The intervention group will be provided a condom catheter. If necessary, the ladder will be assisted with a urine bottle or a toilet chair
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
outcome assessor is masked for intervention
Intervention model description
randomised open label trial
Eligibility
Sex/Gender
MALE
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria * Male gender * Age ≥ 70 years * Treated with recanalization therapy and therefore receiving an IUC * Patient is able to provide written informed consent. If patient is aphasic and not in a position to provide written informed consent after the stroke, a relative or a legal guardian can provide information of the presumed will of the patient. Inclusion of this patient is possible if the patient will give basic informed consent as soon as he is able to and after a maximum of seven days after enrollment. As delirium is associated with stroke severity it is necessary to include these patients, otherwise the incidence of delirium will be too low.
Exclusion criteria
* Delirium at admission * Need for mechanical ventilation \> 48h * Presence of an IUC before admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delirium | 10 days after admission | The primary outcome will be the development of delirium within 10 days after admission. Secondary outcomes will be * Length of stay on NICU / stroke unit * Development of UTI * Development of neurological bladder dysfunction * Pleura effusions and/or ankle edema |
Countries
Germany
Outcome results
None listed