Cerebral Blood Flow During Hemodialysis

University Medical Center Groningen15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Haemodialysis-induced Symptom

Interventions

[15O]H2O PET-CT scanOTHER

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

NIRS (Invos)OTHER

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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