Haemodialysis-induced SymptomNCT02272985
Cerebral Blood Flow During Hemodialysis
A study testing [15O]H2O PET-CT scan and NIRS (Invos) in people with Haemodialysis-induced Symptom, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the effect of the hemodialysis procedure on cerebral blood flow (CBF) in elderly maintenance hemodialysis (HD) patients. The investigators hypothesize that HD induced blood pressure changes are associated with a fall in global and/or regional CBF during HD. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Haemodialysis-induced Symptom
- What is being tested?
- [15O]H2O PET-CT scan and NIRS (Invos)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adult, age ≥ 65 years, HD patients who have been treated with maintenance HD, of which at least 6 patients for a longer period of time (>1 year).
- Patients must have an arteriovenous fistula without recirculation
- The hemoglobin value must be in the target range (6.2 - 8mmol/l) since at least 1 month
Who cannot join
- The absence of informed consent
- Diagnosis of dementia, hydrocephalus, history of raised intracranial pressure, significant (>70%) carotid artery stenosis, end-stage liver disease.
- Actively treated cancer
- Actual hospital admission at timing of HD study session
- MRI incompatible implants in the body or any other contraindication for MRI
- Claustrophobia
- The refusal to be informed of significant carotid artery stenosis or structural brain abnormalities that could be detected during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A [15O]H2O PET-CT Pilot Study Comparing Cerebral Blood Flow Before, During and After Hemodialysis
The purpose of this study is to evaluate the effect of the hemodialysis procedure on cerebral blood flow (CBF) in elderly maintenance hemodialysis (HD) patients. The investigators hypothesize that HD induced blood pressure changes are associated with a fall in global and/or regional CBF during HD. Second, the investigators hypothesize that near infrared spectroscopy (NIRS) will correlate with CBF measured by[15O]H2O PET.
Read the detailed description
The investigators aim to include 14 participants. Each participant will undergo a single HD study session in the PET center of the UMCG. During this study session, each participant will undergo three gated [15O]H2O PET-CT scans before, during (after 20 minutes) and at the end of the HD session. NIRS will be used to measure cerebral tissue regional oxygen saturation (rSO2) during the HD study session. INVOS (In Vivo Optical Spectroscopy), a monitoring device, will be used to measure rSO2, with sensors placed bilaterally on the patient forehead. Participants will further undergo a MRI scan of the brain, bilateral carotid artery duplex echosonography, cognitive testing, blood pressure and heart rate measurements during the HD study session, and laboratory measurements during the HD study session.
- Conditions
- Haemodialysis-induced Symptom
- Being tested
- [15O]H2O PET-CT scan, NIRS (Invos)
- Keywords
- cerebral blood flow, hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[15O]H2O PET-CT scanOther
All participants will undergo 3 [15O]H2O PET-CT scans during the hemodialysis study session
NIRS (Invos)Other
All participants will undergo near infrared spectroscopy (NIRS) during the hemodialysis study session.
| Study group | Role | What they receive |
|---|---|---|
| CBF change during hemodialysis | Other | [15O]H2O PET-CT scan and NIRS (Invos) Receives: Other: [15O]H2O PET-CT scan; Other: NIRS (Invos) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CBF From Baseline (Before Start of the Hemodialysis Study Session), at 20 Minutes, and at the End of the Hemodialysis Study Session, Measured by [15O]H2OPET-CT
Measured: at t= -5 minutes, t= 20 minutes, and at t=220 minutes.The change from baseline (-5min) to the end of hemodialysis (220min) is reported.
Secondary outcomes (1)
Change in rSO2 From Baseline (Before Start of the Hemodialysis Study Session), at 20 Minutes, and at the End of the Hemodialysis Study Session, Measured by NIRS
Change in rSO2, between baseline (-5 minutes) and the end of the hemodialysis (t=220 minutes) study session.
Measured: at t= -5 minutes, t= 20 minutes, and at t=220 minutes.The start of dialysis was considered as t=0. Therefore, baseline is t=-5minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Haemodialysis-induced SymptomStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Martini Hospital Groningen
- Responsible party
- Principal investigator, dr. C.F.M. Franssen, University Medical Center Groningen
- Investigators
- Casper FM Franssen, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272985
- Sponsor's protocol ID
- ABR 48969
- Status last verified
- Apr 2020
- First submitted
- 13 Oct 2014
- Last updated
- 7 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A [15O]H2O PET-CT Pilot Study Comparing Cerebral Blood Flow Before, During and After Hemodialysis
- ClinicalTrials.gov ID
- NCT02272985
- Acronym / sponsor ID
- ABR 48969
- Conditions
- Haemodialysis-induced Symptom
- Keywords
- cerebral blood flow, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Martini Hospital Groningen
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Posted 16 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of the hemodialysis procedure on cerebral blood flow (CBF) in elderly maintenance hemodialysis (HD) patients. The investigators hypothesize that HD induced blood pressure changes are associated with a fall in global and/or regional CBF during HD. Second, the investigators hypothesize that near infrared spectroscopy (NIRS) will correlate with CBF measured by[15O]H2O PET.
Detailed description
The investigators aim to include 14 participants. Each participant will undergo a single HD study session in the PET center of the UMCG. During this study session, each participant will undergo three gated [15O]H2O PET-CT scans before, during (after 20 minutes) and at the end of the HD session. NIRS will be used to measure cerebral tissue regional oxygen saturation (rSO2) during the HD study session. INVOS (In Vivo Optical Spectroscopy), a monitoring device, will be used to measure rSO2, with sensors placed bilaterally on the patient forehead. Participants will further undergo a MRI scan of the brain, bilateral carotid artery duplex echosonography, cognitive testing, blood pressure and heart rate measurements during the HD study session, and laboratory measurements during the HD study session.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBF change during hemodialysis | Other | Other: [15O]H2O PET-CT scan, Other: NIRS (Invos)[15O]H2O PET-CT scan and NIRS (Invos) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Adult, age ≥ 65 years, HD patients who have been treated with maintenance HD, of which at least 6 patients for a longer period of time (>1 year).
- Patients must have an arteriovenous fistula without recirculation
- The hemoglobin value must be in the target range (6.2 - 8mmol/l) since at least 1 month
Key exclusion criteria (7 listed)
- The absence of informed consent
- Diagnosis of dementia, hydrocephalus, history of raised intracranial pressure, significant (>70%) carotid artery stenosis, end-stage liver disease.
- Actively treated cancer
- Actual hospital admission at timing of HD study session
- MRI incompatible implants in the body or any other contraindication for MRI
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 |
|---|---|---|
| [15O]H2O PET-CT scanAll participants will undergo 3 [15O]H2O PET-CT scans during the hemodialysis study session | Other | CBF change during hemodialysis |
| NIRS (Invos)All participants will undergo near infrared spectroscopy (NIRS) during the hemodialysis study session. | Other | CBF change during hemodialysis |
Primary outcome
Change in CBF From Baseline (Before Start of the Hemodialysis Study Session), at 20 Minutes, and at the End of the Hemodialysis Study Session, Measured by [15O]H2OPET-CT
Time frame: at t= -5 minutes, t= 20 minutes, and at t=220 minutes.The change from baseline (-5min) to the end of hemodialysis (220min) is reported.
1 secondary outcome
Change in rSO2 From Baseline (Before Start of the Hemodialysis Study Session), at 20 Minutes, and at the End of the Hemodialysis Study Session, Measured by NIRS
Time frame: at t= -5 minutes, t= 20 minutes, and at t=220 minutes.The start of dialysis was considered as t=0. Therefore, baseline is t=-5minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Casper FM Franssen, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [15O]H2O PET-CT scan and NIRS (Invos) in people with Haemodialysis-induced Symptom, run by University Medical Center Groningen at 1 site in Netherlands.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 7 Apr 2020. 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 Netherlands. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in CBF From Baseline (Before Start of the Hemodialysis Study Session), at 20 Minutes, and at the End of the Hemodialysis Study Session, Measured by [15O]H2OPET-CT (time frame: at t= -5 minutes, t= 20 minutes, and at t=220 minutes.The change from baseline (-5min) to the end of hemodialysis (220min) is reported.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2020.