Clinical trial NCT02272985: Cerebral Blood Flow During Hemodialysis
Official title: A [15O]H2O PET-CT Pilot Study Comparing Cerebral Blood Flow Before, During and After Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemodialysis-induced Symptom
Keywords: cerebral blood flow
hemodialysis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Martini Hospital Groningen
First posted: 2014-10-23
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 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:
measure: 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
timeFrame: 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.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Casper FM Franssen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: