Trial Outcomes & Findings for Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis (NCT NCT00825318)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)

Results posted on

2014-05-26

Participant milestones
Measure	Daily Ultrafiltration During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Withdrawal data not reported

Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis

Baseline characteristics by cohort
Measure	Daily Ultrafiltration n=13 Participants During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50.6 years STANDARD_DEVIATION 8.23 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

Timeframe: Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)

Outcome measures
Measure	Prestudy Phase n=13 Participants During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.	Daily Ultrafiltration Phase n=12 Participants During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.	Return Phase n=12 Participants During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
Mean Arterial Blood Pressure	110 mm Hg Interval 84.0 to 133.0	95 mm Hg Interval 84.0 to 111.0	106 mm Hg Interval 92.0 to 121.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Prestudy Phase n=13 participants at risk During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.	Daily Ultrafiltration Phase n=13 participants at risk During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.	Return Phase n=13 participants at risk During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
Infections and infestations Infection	— 0/0	7.7% 1/13 • Number of events 1	0.00% 0/13
Metabolism and nutrition disorders Elevated Potassium	— 0/0	0.00% 0/13	7.7% 1/13 • Number of events 1
Metabolism and nutrition disorders Elevated Glucose Level	— 0/0	7.7% 1/13 • Number of events 1	0.00% 0/13

Adverse event data not reported

St. Luke's-Roosevelt Hospital Center

Phone: 2125233530