N/A N=15 Diagnostic

Cerebral Blood Flow During Hemodialysis

Haemodialysis-induced Symptom

Bottom Line

View on ClinicalTrials.gov: NCT02272985 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Jan 2019

Primary outcome: Primary: 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 — -4.1 mL/100g/min — p==0.03

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: [15O]H2O PET-CT scan (Other); NIRS (Invos) (Other)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: University Medical Center Groningen
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	-4.1	=0.03 sig
SECONDARY 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	-4.2; -3.1	0.001 sig

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02272985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.