Haemodialysis-induced Symptom
Conditions
Keywords
cerebral blood flow, hemodialysis
Brief 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. 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.
Interventions
OTHER[15O]H2O PET-CT scan
All participants will undergo 3 \[15O\]H2O PET-CT scans during the hemodialysis study session
OTHERNIRS (Invos)
All participants will undergo near infrared spectroscopy (NIRS) during the hemodialysis study session.
Sponsors
Martini Hospital Groningen
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. | Change in rSO2, between baseline (-5 minutes) and the end of the hemodialysis (t=220 minutes) study session. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBF Change During HD Arm/Group is not applicable. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | hip fracture | 1 |
| Overall Study | kidney transplantation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | CBF Change During HD | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 15 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| diabetes | 3 Participants | — |
| dialysis vintage | 47 months | — |
| heart failure | 1 Participants | — |
| hypertension | 11 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Netherlands | 15 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
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
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 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 mL/100g/min |
p-value: =0.03Mixed Models Analysis
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.
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Global CBF Change During HD | 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 | Left rSO2 | -4.2 percentage of regional oxygen saturation |
| Global CBF Change During HD | 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 | Right rSO2 | -3.1 percentage of regional oxygen saturation |
Comparison: Left frontal gray matter:p-value: 0.001Mixed Models Analysis
Comparison: Right frontal gray matter:p-value: 0.08Mixed Models Analysis