NCT02272985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

January 16, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

October 13, 2014

Results QC Date

October 26, 2017

Last Update Submit

April 5, 2020

Conditions

Haemodialysis-induced Symptom

Keywords

cerebral blood flowhemodialysis

Outcome Measures

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

    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

    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.

Study Arms (1)

CBF change during hemodialysis

OTHER

\[15O\]H2O PET-CT scan and NIRS (Invos)

Other: [15O]H2O PET-CT scanOther: NIRS (Invos)

Interventions

[15O]H2O PET-CT scanOTHER

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

CBF change during hemodialysis
NIRS (Invos)OTHER

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

CBF change during hemodialysis

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Dr. C.F.M. Franssen
Organization
University Medical Center Groningen
c.f.m.franssen@umcg.nl
+0031(0)50 3616161

Study Officials

  • Casper FM Franssen, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 23, 2014

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 7, 2020

Results First Posted

January 16, 2019

Record last verified: 2020-04

Locations

NL(1)