An interventional study of [15O]H2O PET-CT scan and NIRS (Invos) in Haemodialysis-induced Symptom, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-04-07.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Diagnostic
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.
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.
University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
\[15O\]H2O PET-CT scan and NIRS (Invos)
Other: [15O]H2O PET-CT scan · Other: NIRS (Invos)
All participants will undergo 3 \[15O\]H2O PET-CT scans during the hemodialysis study session
All participants will undergo near infrared spectroscopy (NIRS) during the hemodialysis study session.
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.
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.
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.
| Milestone | CBF Change |
|---|---|
| Started | 15 |
| Completed | 12 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Hip fracture | 1 |
| Withdrew: Kidney transplantation | 1 |
| mL/100g/min | Global CBF Change During HD |
|---|---|
| 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 | -4.1 (-7.3 to -0.9) |
Change in rSO2, between baseline (-5 minutes) and the end of the hemodialysis (t=220 minutes) study session.
| percentage of regional oxygen saturation | rSO2 Change During Hemodialysis |
|---|---|
| Left rSO2 | -4.2 (-6.6 to -1.8) |
| Right rSO2 | -3.1 (-6.4 to 0.3) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CBF Change During HD | 0/15 (0%) | 1/15 (6.7%) | 0/15 (0%) |
| Event | CBF Change During HD |
|---|---|
| dialysis hypotensionVascular disorders | 1/15 |
| Hip fractureMusculoskeletal and connective tissue disorders | 1/15 |
| Age, Categorical(Participants) | CBF Change During HD |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 15 |
| Sex: Female, Male(Participants) | CBF Change During HD |
|---|---|
| Female | 5 |
| Male | 10 |
| Race and Ethnicity Not Collected(Participants) | CBF Change During HD |
|---|
| Region of Enrollment(participants) | CBF Change During HD |
|---|---|
| Netherlands | 15 |
| dialysis vintage(months) | CBF Change During HD |
|---|---|
| Median | 47 (11 to 319) |
| diabetes(Participants) | CBF Change During HD |
|---|---|
| Count of participants | 3 |
| hypertension(Participants) | CBF Change During HD |
|---|---|
| Count of participants | 11 |
| heart failure(Participants) | CBF Change During HD |
|---|---|
| Count of participants | 1 |
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Medical Center Groningen