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Trial Outcomes & Findings for Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate (NCT NCT00962000)

NCT ID: NCT00962000

Last Updated: 2025-07-24

Results Overview

The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. When urea is removed from a single compartment during dialysis, it is called the "single-pool" Kt/V. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-07-24

Participant Flow

Participant milestones

Participant milestones
Measure
600 mL/Min First
Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
800 mL/Min First
Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.
Period 1 - 1 Week
STARTED
21
21
Period 1 - 1 Week
COMPLETED
21
21
Period 1 - 1 Week
NOT COMPLETED
0
0
Period 2 - 1 Week
STARTED
21
21
Period 2 - 1 Week
COMPLETED
21
21
Period 2 - 1 Week
NOT COMPLETED
0
0
Period 3 - 1 Week
STARTED
21
21
Period 3 - 1 Week
COMPLETED
21
21
Period 3 - 1 Week
NOT COMPLETED
0
0
Period 4 - 1 Week
STARTED
21
21
Period 4 - 1 Week
COMPLETED
21
21
Period 4 - 1 Week
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=42 Participants
All subjects who participated in the study.
Age, Continuous
>=18 years
50 years
n=5 Participants
Sex: Female, Male
Female
16 Participants
n=5 Participants
Sex: Female, Male
Male
26 Participants
n=5 Participants
Pre-dialysis Weight
84 kg
n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. When urea is removed from a single compartment during dialysis, it is called the "single-pool" Kt/V. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA).

Outcome measures

Outcome measures
Measure
600 mL/Min
n=75 Treatments
Dialysate flow rate of 600 mL/min
800 mL/Min
n=77 Treatments
Dialysate flow rate of 800 mL/min
Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.
1.66 single-pool Kt/Vurea (spKt/V)
Standard Deviation 0.25
1.63 single-pool Kt/Vurea (spKt/V)
Standard Deviation 0.21

SECONDARY outcome

Timeframe: 4 weeks

The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. The formula for equilibrated Kt/Vurea takes urea rebound into consideration. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA).

Outcome measures

Outcome measures
Measure
600 mL/Min
n=75 Treatments
Dialysate flow rate of 600 mL/min
800 mL/Min
n=77 Treatments
Dialysate flow rate of 800 mL/min
Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.
1.37 equilibrated Kt/Vurea (eKt/V)
Standard Deviation 0.20
1.35 equilibrated Kt/Vurea (eKt/V)
Standard Deviation 0.18

SECONDARY outcome

Timeframe: 4 weeks

Kt/VID was determined for all study treatments at 2 of the 3 centers using on-line clearance measurements (Gambro Diascan or Fresenius On-line Clearance Monitor).

Outcome measures

Outcome measures
Measure
600 mL/Min
n=140 Treatments
Dialysate flow rate of 600 mL/min
800 mL/Min
n=143 Treatments
Dialysate flow rate of 800 mL/min
Kt/V Determined From Measurements of Ionic Dialysance
1.46 Kt/VID
Standard Deviation 0.24
1.49 Kt/VID
Standard Deviation 0.35

Adverse Events

600 mL/Min First

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

800 mL/Min First

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Global CORP Clinical Trials Disclosure

Vantive

Phone: +1 2249484283

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60