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NCT Number: NCT02272985

Cerebral Blood Flow During 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.

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Key information

Conditions

Haemodialysis-induced Symptom

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[15O]H2O PET-CT scan

Other

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.

Primary outcomes

  1. 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

  1. 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

    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.

    Change in rSO2, between baseline (-5 minutes) and the end of the hemodialysis (t=220 minutes) study session.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Martini Hospital Groningen

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 23, 2014
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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