NCT02621749

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

5.8 years

First QC Date

November 20, 2015

Last Update Submit

November 7, 2022

Conditions

Cerebral Embolism

Outcome Measures

Primary Outcomes (1)

  • Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound

    During hemodialysis therapy

Study Arms (2)

CRRT group

ACTIVE COMPARATOR

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

Device: Renal replacement therapy

IRRT group

ACTIVE COMPARATOR

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

Device: Renal replacement therapy

Interventions

Renal replacement therapyDEVICE

Patients receive renal replacement therapy according to institutional standards

Also known as: Hemodialysis
CRRT groupIRRT group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 yrs.
  • Signed IC

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 29562937DERIVED

MeSH Terms

Conditions

Intracranial Embolism

Interventions

Renal Replacement TherapyRenal Dialysis

Condition Hierarchy (Ancestors)

Intracranial Embolism and ThrombosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesThromboembolismEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

TherapeuticsSorption Detoxification

Study Officials

  • Gabor Erdoes, MD

    University of Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2015

First Posted

December 3, 2015

Study Start

January 1, 2017

Primary Completion

November 6, 2022

Study Completion

November 6, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

CH(1)