Cerebral Microembolism in the Critically Ill With Acute Kidney Injury

NCT ID: NCT02621749

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2022-11-06

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CRRT group

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

Group Type ACTIVE_COMPARATOR

Renal replacement therapy

Intervention Type DEVICE

Patients receive renal replacement therapy according to institutional standards

IRRT group

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

Group Type ACTIVE_COMPARATOR

Renal replacement therapy

Intervention Type DEVICE

Patients receive renal replacement therapy according to institutional standards

Interventions

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Renal replacement therapy

Patients receive renal replacement therapy according to institutional standards

Intervention Type DEVICE

Other Intervention Names

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Hemodialysis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabor Erdoes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Berne

Locations

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University Hospital Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 29562937 (View on PubMed)

Other Identifiers

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199/2015

Identifier Type: -

Identifier Source: org_study_id

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