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COMET-AKI: Cerebral Microembolism in the Critically Ill With Acute Kidney Injury

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT02621749
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
71
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Renal replacement therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CRRT group

the CRRT group receives continuous renal replacement therapy for acute kidney injury

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

    		•
    Active Comparator: IRRT group

    the IRRT group receives intermittent renal replacement therapy after termination of CRRT.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound [During hemodialysis therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Bern Bern Switzerland 3010

    Sponsors and Collaborators

    • University Hospital Inselspital, Berne

    Investigators

    • Principal Investigator: Gabor Erdoes, MD, University of Berne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Inselspital, Berne
    ClinicalTrials.gov Identifier:
    NCT02621749
    Other Study ID Numbers:
    • 199/2015
    First Posted:
    Dec 3, 2015
    Last Update Posted:
    Sep 30, 2021
    Last Verified:
    Nov 1, 2020
    Additional relevant MeSH terms:
    Intracranial Embolism
    Acute Kidney Injury
    Embolism

    Study Results

    No Results Posted as of Sep 30, 2021