Ignite Creation Date:
2024-05-06 @ 3:22 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02272985
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2014-10-13
Brief Title:
Cerebral Blood Flow During Hemodialysis
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
A 15OH2O PET-CT Pilot Study Comparing Cerebral Blood Flow Before During and After Hemodialysis
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor regional CBF during HD Second the investigators hypothesize that near infrared spectroscopy NIRS will correlate with CBF measured by15OH2O 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 15OH2O 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None