Cerebral Blood Flow During Hemodialysis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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

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Haemodialysis-induced Symptom

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CBF change during hemodialysis

\[15O\]H2O PET-CT scan and NIRS (Invos)

Group Type OTHER

[15O]H2O PET-CT scan

Intervention Type OTHER

All participants will undergo 3 \[15O\]H2O PET-CT scans during the hemodialysis study session

NIRS (Invos)

Intervention Type OTHER

All participants will undergo near infrared spectroscopy (NIRS) during the hemodialysis study session.

Interventions

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[15O]H2O PET-CT scan

All participants will undergo 3 \[15O\]H2O PET-CT scans during the hemodialysis study session

Intervention Type OTHER

NIRS (Invos)

All participants will undergo near infrared spectroscopy (NIRS) during the hemodialysis study session.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No