Cerebral Blood Flow During Hemodialysis

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Haemodialysis-induced Symptom

Treatments: Other: NIRS (Invos); Other: [15O]H2O PET-CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02272985

ABR 48969

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

CBF change during hemodialysis

Other group

Description:

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

Treatment:

Other: NIRS (Invos)

Other: [15O]H2O PET-CT scan