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

Primary Purpose

Cerebral Embolism

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Renal replacement therapy
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CRRT group

IRRT group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound

Secondary Outcome Measures

Full Information

First Posted
November 20, 2015
Last Updated
November 7, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT02621749
Brief Title
Cerebral Microembolism in the Critically Ill With Acute Kidney Injury
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
January 2017 (undefined)
Primary Completion Date
November 6, 2022 (Actual)
Study Completion Date
November 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRRT group
Arm Type
Active Comparator
Arm Description
the CRRT group receives continuous renal replacement therapy for acute kidney injury
Arm Title
IRRT group
Arm Type
Active Comparator
Arm Description
the IRRT group receives intermittent renal replacement therapy after termination of CRRT.
Intervention Type
Device
Intervention Name(s)
Renal replacement therapy
Other Intervention Name(s)
Hemodialysis
Intervention Description
Patients receive renal replacement therapy according to institutional standards
Primary Outcome Measure Information:
Title
Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound
Time Frame
During hemodialysis therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabor Erdoes, MD
Organizational Affiliation
University of Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29562937
Citation
Erdoes G, Uehlinger DE, Kobel B, Stucki MP, Wiest R, Stueber F, Fankhauser N, Jakob SM, Schefold JC. Cerebral microembolism in the critically ill with acute kidney injury (COMET-AKI trial): study protocol for a randomized controlled clinical trial. Trials. 2018 Mar 21;19(1):189. doi: 10.1186/s13063-018-2561-3.
Results Reference
derived

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Cerebral Microembolism in the Critically Ill With Acute Kidney Injury

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