Delirium Incidence and Indwelling Urinary CathEterization After Acute Stroke (DICES)

University Hospital Tuebingen

Status: Terminated

Conditions: Post-Stroke Delirium

Treatments: Device: condom catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT07264244

144/2021BO1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Male

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

usual care (IUC)

No Intervention group

condom catheter

Active Comparator group

Treatment:

Device: condom catheter