Trial Outcomes & Findings for Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration (NCT NCT01923961)
NCT ID: NCT01923961
Last Updated: 2019-01-16
Results Overview
Determination of reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
4 hours
Results posted on
2019-01-16
Participant Flow
Participant milestones
| Measure |
HDF NaCl Infusion, Then HD, Then Standard Pre-HDF
Participants first received hemodiafiltration with infusion of 5 M NaCl for 4 hours. After a washout period of 1 week, they then received 4 hours of bicarbonate hemodialysis. After another washout period of 1 week, they reveived 4 hours of standard predilution hemodiafiltration.
|
HD, Then Standard Pre-HDF, Then HDF NaCl Infusion
Participants first received bicarbonate hemodialysis for 4 hours. After a washout period of 1 week, they then received 4 hours of standard predilution hemodiafiltration. After another washout period of 1 week, they reveived 4 hours of hemodiafiltration with infusion of 5 M NaCl.
|
Standard Pre-HDF, Then HDF NaCl Infusion, Then HD
Participants first received standard predilution hemodiafiltration for 4 hours. After a washout period of 1 week, they then received 4 hours of hemodiafiltration with infusion of 5 M NaCl. After another washout period of 1 week, they reveived 4 hours of bicarbonate hemodialysis.
|
|---|---|---|---|
|
First Intervention
STARTED
|
3
|
3
|
2
|
|
First Intervention
COMPLETED
|
3
|
3
|
2
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
3
|
3
|
2
|
|
Washout (1 Week)
COMPLETED
|
3
|
3
|
2
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
3
|
3
|
2
|
|
Second Intervention
COMPLETED
|
3
|
3
|
2
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
3
|
3
|
2
|
|
Third Intervention
COMPLETED
|
3
|
3
|
2
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration
Baseline characteristics by cohort
| Measure |
Standard Pre-HDF, Then HDF NaCl, Then HD
n=2 Participants
Participants first received standard predilution hemodiafiltration for 4 hours. After a washout period of 1 week, they then received 4 hours of hemodiafiltration with infusion of 5 M NaCl. After another washout period of 1 week, they reveived 4 hours of bicarbonate hemodialysis.
|
Total
n=8 Participants
Total of all reporting groups
|
HDF NaCl, Then HD, Then Standard Pre-HDF
n=3 Participants
Participants first received hemodiafiltration with infusion of 5 M NaCl for 4 hours. After a washout period of 1 week, they then received 4 hours of bicarbonate hemodialysis. After another washout period of 1 week, they reveived 4 hours of standard predilution hemodiafiltration.
|
HD, Then Standard Pre-HDF, Then HDF NaCl
n=3 Participants
Participants first received bicarbonate hemodialysis for 4 hours. After a washout period of 1 week, they then received 4 hours of standard predilution hemodiafiltration. After another washout period of 1 week, they reveived 4 hours of hemodiafiltration with infusion of 5 M NaCl.
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
62 years
n=4 Participants
|
62 years
n=5 Participants
|
62 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
|
Sodium Chloride (NaCl) Infusion
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: Per protocol population
Determination of reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention
Outcome measures
| Measure |
Hemodiafiltration, NaCl Infusion
n=8 Participants
5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration.
5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma.
|
Hemodialysis
n=8 Participants
Standard bicarbonate high-flux hemodialysis
|
Hemodiafiltration
n=8 Participants
Standard predilution Hemodiafiltration
|
|---|---|---|---|
|
Removal of Para-cresylsulfate
|
42.0 percentage of reduction
Standard Deviation 22.1
|
32.6 percentage of reduction
Standard Deviation 18.5
|
33.6 percentage of reduction
Standard Deviation 16.1
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: Per protocol analysis
Determination of the reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention
Outcome measures
| Measure |
Hemodiafiltration, NaCl Infusion
n=8 Participants
5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration.
5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma.
|
Hemodialysis
n=8 Participants
Standard bicarbonate high-flux hemodialysis
|
Hemodiafiltration
n=8 Participants
Standard predilution Hemodiafiltration
|
|---|---|---|---|
|
Removal of Indoxylsulfate
|
34.8 percentage of reduction
Standard Deviation 23.5
|
26.5 percentage of reduction
Standard Deviation 18.1
|
30.9 percentage of reduction
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Per protocol analysis
Maximum arterial sodium concentrations
Outcome measures
| Measure |
Hemodiafiltration, NaCl Infusion
n=8 Participants
5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration.
5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma.
|
Hemodialysis
n=8 Participants
Standard bicarbonate high-flux hemodialysis
|
Hemodiafiltration
n=8 Participants
Standard predilution Hemodiafiltration
|
|---|---|---|---|
|
Plasma Sodium Concentrations
|
136 mval/l
Standard Deviation 3
|
133 mval/l
Standard Deviation 2
|
134 mval/l
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Per protocol analysis
Maximum free hemoglobin in plasma, which indicates hemolysis. Hemoglobin is released into plasma in case of red blood cell destruction.
Outcome measures
| Measure |
Hemodiafiltration, NaCl Infusion
n=8 Participants
5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration.
5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma.
|
Hemodialysis
n=8 Participants
Standard bicarbonate high-flux hemodialysis
|
Hemodiafiltration
n=8 Participants
Standard predilution Hemodiafiltration
|
|---|---|---|---|
|
Hemocompatibility
|
0.09 percentage of total hemoglobin
Standard Deviation 0.04
|
0.07 percentage of total hemoglobin
Standard Deviation 0.03
|
0.08 percentage of total hemoglobin
Standard Deviation 0.02
|
Adverse Events
Hemodiafiltration, NaCl Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hemodialysis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hemodiafiltration
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place