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

November 7, 2022 updated by: University Hospital Inselspital, Berne

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound
Time Frame: During hemodialysis therapy
During hemodialysis therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

November 6, 2022

Study Completion (Actual)

November 6, 2022

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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