Cerebral Blood Flow During Hemodialysis

Haemodialysis-induced Symptom Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272985
• Other study ID #: ABR 48969
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: November 2015

Study information

• Verified date: April 2020
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Haemodialysis-induced Symptom

Intervention

Other:
• [15O]H2O PET-CT scan
All participants will undergo 3 [15O]H2O PET-CT scans during the hemodialysis study session
• NIRS (Invos)
All participants will undergo near infrared spectroscopy (NIRS) during the hemodialysis study session.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Martini Hospital Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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		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	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.