Cerebral Blood Flow During Hemodialysis

A [15O]H2O PET-CT Pilot Study Comparing Cerebral Blood Flow Before, During and After Hemodialysis

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.

Study Overview

• Status: Completed
• Conditions: Haemodialysis-induced Symptom
• Intervention / Treatment: Other: [15O]H2O PET-CT scan; Other: NIRS (Invos)

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CBF change during hemodialysis; [15O]H2O PET-CT scan and NIRS (Invos)	Other: [15O]H2O PET-CT scan; All participants will undergo 3 [15O]H2O PET-CT scans during the hemodialysis study session; Other: NIRS (Invos); All participants will undergo near infrared spectroscopy (NIRS) during the hemodialysis study session.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Martini Hospital Groningen
• Investigators: Principal Investigator: Casper FM Franssen, MD, PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 5, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: hemodialysis; cerebral blood flow
• Other Study ID Numbers: ABR 48969