Trial Outcomes & Findings for Expanded Hemodialysis Versus Online Hemodiafiltration (NCT NCT03274518)
NCT ID: NCT03274518
Last Updated: 2019-09-30
Results Overview
Beta-2-Microglobulin clearance
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
One month after starting protocol
Results posted on
2019-09-30
Participant Flow
Participant milestones
| Measure |
Online Hemodiafiltration
Arm description: Online Hemodiafiltration first, then expanded hemodialysis.
First, patients changed fom conventional HD to online hemodiafiltration for 1 month.
Then, patients returned to conventional HD for 2 weeks (washout period). Then, patients underwent the second intervention (expanded hemodialysis) for 1 month, in a cross-over design.
|
Expanded Hemodialysis
Arm description: expanded hemodialysis first, then online hemodiafiltration.
Intervention: Conversion from conventional HD to expanded hemodialysis for 1 month.
Then, patients returned to conventional HD for 2 weeks (washout period). Then, they underwent the second intervention (online hemodiafiltration), for 1 month, in a cross-over design.
|
|---|---|---|
|
First Intervention
STARTED
|
8
|
8
|
|
First Intervention
COMPLETED
|
8
|
8
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
8
|
8
|
|
Washout Period
COMPLETED
|
8
|
8
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
8
|
8
|
|
Second Intervention
COMPLETED
|
8
|
8
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Expanded Hemodialysis Versus Online Hemodiafiltration
Baseline characteristics by cohort
| Measure |
Online Hemodiafiltration
n=8 Participants
Patients were included in this study group per sequence:
Online hemodiafiltration (olHDF) first for 1 month, then expanded hemodialysis (HDx) for 1 month.
Baseline characteristics assessed:
* Age
* Gender
* Ethnicity
* Region of Enrollment
* Serum Beta-2 Microglobulin
|
Expanded Hemodialysis
n=8 Participants
Patients were included in this study group per sequence:
Expanded hemodialysis (HDx) first for 1 month, then online hemodiafiltration (olHDF) for 1 month.
Baseline characteristics assessed:
* Age
* Gender
* Ethnicity
* Region of Enrollment
* Serum Beta-2 Microglobulin
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
39.5 years
n=5 Participants
|
46 years
n=7 Participants
|
39.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Serum Beta-2 Microglobulin
|
23.2 mcg/ml
STANDARD_DEVIATION 6.9 • n=5 Participants
|
27.8 mcg/ml
STANDARD_DEVIATION 5.5 • n=7 Participants
|
25.2 mcg/ml
STANDARD_DEVIATION 6.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: One month after starting protocolPopulation: Beta-2 Microglobulin clearance (ml/min)
Beta-2-Microglobulin clearance
Outcome measures
| Measure |
Online Hemodiafiltration
n=16 Participants
The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.
The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.
|
Expanded Hemodialysis
n=16 Participants
High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin.
|
|---|---|---|
|
Medium Molecule Clearance
|
53 ml/min
Interval 41.8 to 63.7
|
59.5 ml/min
Interval 50.5 to 70.0
|
PRIMARY outcome
Timeframe: One month after starting protocolPopulation: Beta-2-microglobulin mass extraction (mg)
Beta-2-Microglobulin extraction
Outcome measures
| Measure |
Online Hemodiafiltration
n=16 Participants
The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.
The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.
|
Expanded Hemodialysis
n=16 Participants
High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin.
|
|---|---|---|
|
Medium Molecule Removal
|
198 mg
Standard Deviation 81
|
239 mg
Standard Deviation 86
|
SECONDARY outcome
Timeframe: Cardiac output (liters per minute) one month after starting protocolPopulation: Intradialytic cardiac output variation (post-pre dialysis), l/min
noninvasive cardiac output assessment
Outcome measures
| Measure |
Online Hemodiafiltration
n=16 Participants
The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.
The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.
|
Expanded Hemodialysis
n=16 Participants
High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin.
|
|---|---|---|
|
Intradialytic Hemodynamics
|
-1.3 l/min
Interval -2.2 to -0.3
|
-1.4 l/min
Interval -3.0 to -1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One month after starting protocolnoninvasive assessment of extracellular and total body water
Outcome measures
| Measure |
Online Hemodiafiltration
n=16 Participants
The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.
The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.
|
Expanded Hemodialysis
n=16 Participants
High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin.
|
|---|---|---|
|
Fluid Status
|
0.39 liter/liter
Standard Deviation 0.01
|
0.385 liter/liter
Standard Deviation 0.01
|
Adverse Events
Online Hemodiafiltration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Expanded Hemodialysis
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