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| Name | Class |
|---|---|
| Martini Hospital Groningen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBF change during hemodialysis | Other | [15O]H2O PET-CT scan and NIRS (Invos) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [15O]H2O PET-CT scan | Other | All participants will undergo 3 [15O]H2O PET-CT scans during the hemodialysis study session |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Casper FM Franssen, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | CBF Change | Hemodialysis patients that underwent 3 PET-scans during a hemodialysis study-session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CBF Change During HD | Arm/Group is not applicable. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | mL/100g/min | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBF Change During HD | 0 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dialysis hypotension | Vascular disorders | Systematic Assessment | The patient experienced dialysis hypotension at the end of the hemodialysis session. This patient had a history of dialysis hypotension episodes. He made an uneventful recovery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. C.F.M. Franssen | University Medical Center Groningen | +0031(0)50 3616161 | c.f.m.franssen@umcg.nl |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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| NIRS (Invos) | Other | All participants will undergo near infrared spectroscopy (NIRS) during the hemodialysis study session. |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| dialysis vintage | Three patients withdrew their consent before the actual start of the study. Therefore, we did not include them in the analyses. | Median | Full Range | months |
|
| diabetes | Three patients withdrew their consent before the actual start of the study. Therefore, we did not include them in the analyses. | Count of Participants | Participants |
|
| hypertension | Three patients withdrew their consent before the actual start of the study. Therefore, we did not include them in the analyses. | Count of Participants | Participants |
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| heart failure | Three patients withdrew their consent before the actual start of the study. Therefore, we did not include them in the analyses. | Count of Participants | Participants |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | percentage of regional oxygen saturation | 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. |
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| 1 |
| 15 |
| 0 |
| 15 |
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| Hip fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | The patient experienced a hip fracture just after signing informed consent but before the study was started. |
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| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| 0.08 |
| Other |