Cerebral Microembolism in the Critically Ill With Acute Kidney Injury

Cerebral Embolism Clinical Trial

— COMET-AKI  

Official title:

Cerebral Microembolism in the Critically Ill With Acute Kidney Injury: A Prospective Multi-Center Randomized Controlled Trial Comparing Continuous With Intermittent Renal Replacement Therapy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02621749
• Other study ID #: 199/2015
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 6, 2022

Study information

• Verified date: November 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to investigate the impact of continuous renal replacement therapy and intermittent renal replacement therapy on microbubble / cerebral microemboli generation in a cohort of critically ill patients with dialysis-dependent acute kidney injury.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: November 6, 2022
• Est. primary completion date: November 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 yrs.
• Signed IC

Exclusion Criteria:

• Heart disease (PFO, ASD, VSD, severe valvular disease)
• Atrial fibrillation
• Cerebrovascular pathology
• Missing temporal bone window
• Allergy to plastic contained in the investigative device (transcranial Doppler)
• Chronic kidney disease
• Pregnancy
• Participation in another study

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cerebral Embolism
• Embolism
• Intracranial Embolism

Intervention

Device:
• Renal replacement therapy
Patients receive renal replacement therapy according to institutional standards

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound		During hemodialysis therapy