NCT07264244

Delirium Incidence and Indwelling Urinary CathEterization After Acute Stroke

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: Male
• Age: 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-03-31
• Completion: 2023-03-31
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: Germany