Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00962000
Recruitment Status : Completed
First Posted : August 19, 2009
Results First Posted : July 21, 2011
Last Update Posted : May 10, 2017
Sponsor:
Collaborators:
University of Louisville
Vanderbilt University Medical Center
University of California, Davis
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease
Chronic Renal Disease
Interventions Other: Dialysis Flow Rate Start 600mL/min
Other: Dialysis Flow Rate Start 800mL/min
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 600 mL/Min First 800 mL/Min First
Hide Arm/Group Description 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. 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 Title: Period 1 - 1 Week
Started 21 21
Completed 21 21
Not Completed 0 0
Period Title: Period 2 - 1 Week
Started 21 21
Completed 21 21
Not Completed 0 0
Period Title: Period 3 - 1 Week
Started 21 21
Completed 21 21
Not Completed 0 0
Period Title: Period 4 - 1 Week
Started 21 21
Completed 21 21
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All subjects who participated in the study.
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
>=18 years Number Analyzed 42 participants
50
(19 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
16
  38.1%
Male
26
  61.9%
Pre-dialysis Weight  
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 42 participants
84
(48 to 147)
1.Primary Outcome
Title Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.
Hide Description 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).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 600 mL/Min 800 mL/Min
Hide Arm/Group Description:
Dialysate flow rate of 600 mL/min
Dialysate flow rate of 800 mL/min
Overall Number of Participants Analyzed 42 42
Overall Number of Units Analyzed
Type of Units Analyzed: Treatments
75 77
Mean (Standard Deviation)
Unit of Measure: single-pool Kt/Vurea (spKt/V)
1.66  (0.25) 1.63  (0.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 600 mL/Min, 800 mL/Min
Comments Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments There is no p values because the power calculation is based on the primary outcome variable
Method ANOVA
Comments The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.024
Confidence Interval (2-Sided) 95%
-0.064 to 0.024
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02217
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.
Hide Description 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).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 600 mL/Min 800 mL/Min
Hide Arm/Group Description:
Dialysate flow rate of 600 mL/min
Dialysate flow rate of 800 mL/min
Overall Number of Participants Analyzed 42 42
Overall Number of Units Analyzed
Type of Units Analyzed: Treatments
75 77
Mean (Standard Deviation)
Unit of Measure: equilibrated Kt/Vurea (eKt/V)
1.37  (0.20) 1.35  (0.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 600 mL/Min, 800 mL/Min
Comments Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments There is no p value for eKt/V because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.
Method ANOVA
Comments The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.014
Confidence Interval (2-Sided) 95%
-0.051 to 0.023
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.01849
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Kt/V Determined From Measurements of Ionic Dialysance
Hide Description 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).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 600 mL/Min 800 mL/Min
Hide Arm/Group Description:
Dialysate flow rate of 600 mL/min
Dialysate flow rate of 800 mL/min
Overall Number of Participants Analyzed 28 28
Overall Number of Units Analyzed
Type of Units Analyzed: Treatments
140 143
Mean (Standard Deviation)
Unit of Measure: Kt/VID
1.46  (0.24) 1.49  (0.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 600 mL/Min, 800 mL/Min
Comments Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments There is no p value for Kt/VID because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.035
Confidence Interval 95%
-0.029 to 0.099
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.03103
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 600 mL/Min First 800 mL/Min First
Hide Arm/Group Description 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. 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.
All-Cause Mortality
600 mL/Min First 800 mL/Min First
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
600 mL/Min First 800 mL/Min First
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
600 mL/Min First 800 mL/Min First
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard A. Ward, Ph.D.
Organization: University of Louisville Kidney Disease Program
Phone: 502-852-5757
EMail: richard.ward@louisville.edu
Layout table for additonal information
Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00962000    
Other Study ID Numbers: Gambro PI 2009
First Submitted: August 18, 2009
First Posted: August 19, 2009
Results First Submitted: June 22, 2011
Results First Posted: July 21, 2011
Last Update Posted: May 10, 2017