Delirium Incidence and Indwelling Urinary CathEterization After Acute Stroke

NCT ID: NCT07264244

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-03-31

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.

Conditions

Post-Stroke Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

usual care (IUC)

Group Type: NO_INTERVENTION

No interventions assigned to this group

condom catheter

Group Type: ACTIVE_COMPARATOR

condom catheter

Intervention Type: DEVICE

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

Interventions

condom 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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annerose Mengel, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklnikum Tübingen

Locations

University Medicine Tuebingen

Tübingen, , Germany

Countries

Germany

Other Identifiers

144/2021BO1

Identifier Type: -

Identifier Source: org_study_id