Trial Outcomes & Findings for Cerebral Blood Flow During Hemodialysis (NCT NCT02272985)

Last Updated: 2020-04-07

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

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.

Results posted on

2020-04-07

Participant milestones
Measure	CBF Change Hemodialysis patients that underwent 3 PET-scans during a hemodialysis study-session.
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	CBF Change Hemodialysis patients that underwent 3 PET-scans during a hemodialysis study-session.
Overall Study Withdrawal by Subject	1
Overall Study hip fracture	1
Overall Study kidney transplantation	1

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	CBF Change During HD n=15 Participants Arm/Group is not applicable.
Age, Categorical <=18 years	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=15 Participants
Age, Categorical >=65 years	15 Participants n=15 Participants
Sex: Female, Male Female	5 Participants n=15 Participants
Sex: Female, Male Male	10 Participants n=15 Participants
Region of Enrollment Netherlands	15 participants n=15 Participants
dialysis vintage	47 months n=12 Participants • Three patients withdrew their consent before the actual start of the study. Therefore, we did not include them in the analyses.
diabetes	3 Participants n=12 Participants • Three patients withdrew their consent before the actual start of the study. Therefore, we did not include them in the analyses.
hypertension	11 Participants n=12 Participants • Three patients withdrew their consent before the actual start of the study. Therefore, we did not include them in the analyses.
heart failure	1 Participants n=12 Participants • Three patients withdrew their consent before the actual start of the study. Therefore, we did not include them in the analyses.

Timeframe: 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.

Outcome measures
Measure	Global CBF Change During HD n=12 Participants All patients (n=12)
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 Interval -7.3 to -0.9

Timeframe: 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.

Outcome measures
Measure	Global CBF Change During HD n=12 Participants All patients (n=12)
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 Left rSO2	-4.2 percentage of regional oxygen saturation Interval -6.6 to -1.8
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 Right rSO2	-3.1 percentage of regional oxygen saturation Interval -6.4 to 0.3

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	CBF Change During HD n=15 participants at risk
Vascular disorders dialysis hypotension	6.7% 1/15 • Number of events 1
Musculoskeletal and connective tissue disorders Hip fracture	6.7% 1/15 • Number of events 1

Adverse event data not reported

University Medical Center Groningen

Phone: +0031(0)50 3616161