Cerebral EmbolismCOMET-AKINCT02621749
Cerebral Microembolism in the Critically Ill With Acute Kidney Injury
A study testing Renal replacement therapy in people with Cerebral Embolism, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Embolism
- What is being tested?
- Renal replacement therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2017to 6 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 yrs.
- Signed IC
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Cerebral Embolism
- Being tested
- Renal replacement therapy
- Medical subject headings
- Intracranial Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal replacement therapyDevice
Also called Hemodialysis
Patients receive renal replacement therapy according to institutional standards
| Study group | Role | What they receive |
|---|---|---|
| CRRT group | Active comparator | the CRRT group receives continuous renal replacement therapy for acute kidney injury Receives: Device: Renal replacement therapy |
| IRRT group | Active comparator | the IRRT group receives intermittent renal replacement therapy after termination of CRRT. Receives: Device: Renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound
Measured: During hemodialysis therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJan 2017
- Primary completion6 Nov 2022
- Study completion6 Nov 2022
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral EmbolismStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabor Erdoes, MD, Principal investigator, University of Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621749
- Sponsor's protocol ID
- 199/2015
- Acronym
- COMET-AKI
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2015
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29562937
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02621749
- Acronym / sponsor ID
- COMET-AKI / 199/2015
- Conditions
- Cerebral Embolism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 6 Nov 2022 (actual)
- Study completion
- 6 Nov 2022 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRRT group | Active comparator | Device: Renal replacement therapythe CRRT group receives continuous renal replacement therapy for acute kidney injury |
| IRRT group | Active comparator | Device: Renal replacement therapythe IRRT group receives intermittent renal replacement therapy after termination of CRRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 yrs.
- Signed IC
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal replacement therapyAlso: HemodialysisPatients receive renal replacement therapy according to institutional standards | Device | CRRT group, IRRT group |
Primary outcome
Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound
Time frame: During hemodialysis therapy
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 29562937Erdoes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabor Erdoes, MD principal investigator
University of Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal replacement therapy in people with Cerebral Embolism, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound (time frame: During hemodialysis therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02621749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.