Trial Outcomes & Findings for Acid-Base Composition With Use of hemoDialysates (NCT NCT02334267)
NCT ID: NCT02334267
Last Updated: 2017-03-09
Results Overview
Quantification of Peridialytic Arterialized Blood Bicarbonate Concentrations
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis
Results posted on
2017-03-09
Participant Flow
Participant milestones
| Measure |
Group 1 Week 1 GranuFlo and Week 2 NaturaLyte
Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
GranuFlow: Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
|
Group 2 Week 1 NaturaLyte and Week 2 GranuFlo
Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
NaturaLyte: Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acid-Base Composition With Use of hemoDialysates
Baseline characteristics by cohort
| Measure |
Group 1Week 1 GranuFlo and Week 2 NaturaLyte
n=6 Participants
Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
GranuFlow: Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
|
Group 2 Week 1 NaturaLyte and Week 2 GranuFlo
n=5 Participants
Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
NaturaLyte: Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysisPopulation: Per Protocol Population
Quantification of Peridialytic Arterialized Blood Bicarbonate Concentrations
Outcome measures
| Measure |
GranuFlo
n=10 Participants
The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
|
NaturaLyte
n=10 Participants
The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
|
|---|---|---|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
Pre-dialysis
|
25.7 mEq/l
Standard Deviation 3.33
|
27.1 mEq/l
Standard Deviation 3.28
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
25 min of dialysis
|
27.2 mEq/l
Standard Deviation 3.16
|
27.4 mEq/l
Standard Deviation 3.69
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
60 min of dialysis
|
28.9 mEq/l
Standard Deviation 3.48
|
28.4 mEq/l
Standard Deviation 4.20
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
90 min of dialysis
|
29.2 mEq/l
Standard Deviation 3.85
|
28.6 mEq/l
Standard Deviation 4.14
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
120 min of dialysis
|
29.3 mEq/l
Standard Deviation 3.89
|
28.3 mEq/l
Standard Deviation 3.95
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
150 min of dialysis
|
29.2 mEq/l
Standard Deviation 3.77
|
28.3 mEq/l
Standard Deviation 3.80
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
180 min of dialysis
|
29.6 mEq/l
Standard Deviation 4.09
|
28.3 mEq/l
Standard Deviation 3.71
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
210 min of dialysis
|
30.1 mEq/l
Standard Deviation 3.90
|
29.1 mEq/l
Standard Deviation 3.90
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
240 min of dialysis
|
30.2 mEq/l
Standard Deviation 4.16
|
28.8 mEq/l
Standard Deviation 4.26
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
15 min post-dialysis
|
30.8 mEq/l
Standard Deviation 4.34
|
29.9 mEq/l
Standard Deviation 4.18
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
30 min post-dialysis
|
30.9 mEq/l
Standard Deviation 4.28
|
29.8 mEq/l
Standard Deviation 4.21
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
45 min post-dialysis
|
31.2 mEq/l
Standard Deviation 3.91
|
29.8 mEq/l
Standard Deviation 4.26
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
60 min post-dialysis
|
31.4 mEq/l
Standard Deviation 3.64
|
30.5 mEq/l
Standard Deviation 4.60
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
75 min post-dialysis
|
31.6 mEq/l
Standard Deviation 4.10
|
29.6 mEq/l
Standard Deviation 4.27
|
|
Peridialytic Arterialized Blood Bicarbonate Concentrations
90 min post-dialysis
|
31.2 mEq/l
Standard Deviation 4.44
|
29.8 mEq/l
Standard Deviation 4.37
|
PRIMARY outcome
Timeframe: 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysisPopulation: Per Protocol Population
Quantification of Peridialytic Venous Blood Bicarbonate Concentrations
Outcome measures
| Measure |
GranuFlo
n=10 Participants
The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
|
NaturaLyte
n=10 Participants
The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
|
|---|---|---|
|
Peridialytic Venous Blood Bicarbonate Concentrations
25 min of dialysis
|
29.4 mEq/l
Standard Deviation 3.13
|
30.8 mEq/l
Standard Deviation 3.71
|
|
Peridialytic Venous Blood Bicarbonate Concentrations
60 min of dialysis
|
30.7 mEq/l
Standard Deviation 3.83
|
30.7 mEq/l
Standard Deviation 3.89
|
|
Peridialytic Venous Blood Bicarbonate Concentrations
90 min of dialysis
|
30.2 mEq/l
Standard Deviation 3.36
|
31.2 mEq/l
Standard Deviation 3.71
|
|
Peridialytic Venous Blood Bicarbonate Concentrations
120 min of dialysis
|
30.7 mEq/l
Standard Deviation 3.30
|
30.6 mEq/l
Standard Deviation 3.69
|
|
Peridialytic Venous Blood Bicarbonate Concentrations
150 min of dialysis
|
30.8 mEq/l
Standard Deviation 3.58
|
30.4 mEq/l
Standard Deviation 3.84
|
|
Peridialytic Venous Blood Bicarbonate Concentrations
180 min of dialysis
|
31.0 mEq/l
Standard Deviation 3.83
|
31.3 mEq/l
Standard Deviation 3.65
|
|
Peridialytic Venous Blood Bicarbonate Concentrations
210 min of dialysis
|
30.3 mEq/l
Standard Deviation 3.94
|
31.0 mEq/l
Standard Deviation 3.89
|
|
Peridialytic Venous Blood Bicarbonate Concentrations
240 min of dialysis
|
30.6 mEq/l
Standard Deviation 3.92
|
30.9 mEq/l
Standard Deviation 3.96
|
PRIMARY outcome
Timeframe: Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysisPopulation: Per Protocol Population
Quantification of Peridialytic Arterialized Blood Acetate Concentrations
Outcome measures
| Measure |
GranuFlo
n=10 Participants
The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
|
NaturaLyte
n=10 Participants
The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
|
|---|---|---|
|
Peridialytic Arterialized Blood Acetate Concentrations
45 min post-dialysis
|
0.2 mmol/L
Standard Deviation 0.35
|
0.1 mmol/L
Standard Deviation 0.24
|
|
Peridialytic Arterialized Blood Acetate Concentrations
60 min post-dialysis
|
0.6 mmol/L
Standard Deviation 1.05
|
0.2 mmol/L
Standard Deviation 0.27
|
|
Peridialytic Arterialized Blood Acetate Concentrations
Pre-dialysis
|
0.4 mmol/L
Standard Deviation 0.35
|
0.4 mmol/L
Standard Deviation 0.32
|
|
Peridialytic Arterialized Blood Acetate Concentrations
25 min of dialysis
|
0.5 mmol/L
Standard Deviation 0.29
|
0.4 mmol/L
Standard Deviation 0.28
|
|
Peridialytic Arterialized Blood Acetate Concentrations
60 min of dialysis
|
0.3 mmol/L
Standard Deviation 0.22
|
0.2 mmol/L
Standard Deviation 0.12
|
|
Peridialytic Arterialized Blood Acetate Concentrations
90 min of dialysis
|
0.4 mmol/L
Standard Deviation 0.57
|
0.1 mmol/L
Standard Deviation 0.12
|
|
Peridialytic Arterialized Blood Acetate Concentrations
120 min of dialysis
|
0.3 mmol/L
Standard Deviation 0.18
|
0.1 mmol/L
Standard Deviation 0.18
|
|
Peridialytic Arterialized Blood Acetate Concentrations
150 min of dialysis
|
0.2 mmol/L
Standard Deviation 0.18
|
0.1 mmol/L
Standard Deviation 0.12
|
|
Peridialytic Arterialized Blood Acetate Concentrations
180 min of dialysis
|
0.2 mmol/L
Standard Deviation 0.20
|
0.1 mmol/L
Standard Deviation 0.11
|
|
Peridialytic Arterialized Blood Acetate Concentrations
210 min of dialysis
|
0.3 mmol/L
Standard Deviation 0.21
|
0.2 mmol/L
Standard Deviation 0.31
|
|
Peridialytic Arterialized Blood Acetate Concentrations
240 min of dialysis
|
0.4 mmol/L
Standard Deviation 0.58
|
0.2 mmol/L
Standard Deviation 0.21
|
|
Peridialytic Arterialized Blood Acetate Concentrations
15 min post-dialysis
|
0.0 mmol/L
Standard Deviation 0.05
|
0.1 mmol/L
Standard Deviation 0.13
|
|
Peridialytic Arterialized Blood Acetate Concentrations
30 min post-dialysis
|
0.1 mmol/L
Standard Deviation 0.28
|
0.1 mmol/L
Standard Deviation 0.17
|
|
Peridialytic Arterialized Blood Acetate Concentrations
75 min post-dialysis
|
0.4 mmol/L
Standard Deviation 0.61
|
0.6 mmol/L
Standard Deviation 0.74
|
|
Peridialytic Arterialized Blood Acetate Concentrations
90 min post-dialysis
|
0.4 mmol/L
Standard Deviation 0.61
|
0.4 mmol/L
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysisPopulation: Per Protocol Population
Quantification of Peridialytic Venous Blood Acetate Concentrations
Outcome measures
| Measure |
GranuFlo
n=10 Participants
The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
|
NaturaLyte
n=10 Participants
The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
|
|---|---|---|
|
Peridialytic Venous Blood Acetate Concentrations
210 min of dialysis
|
1.9 mmol/L
Standard Deviation 0.83
|
1.1 mmol/L
Standard Deviation 0.85
|
|
Peridialytic Venous Blood Acetate Concentrations
240 min of dialysis
|
1.7 mmol/L
Standard Deviation 0.90
|
1.2 mmol/L
Standard Deviation 0.84
|
|
Peridialytic Venous Blood Acetate Concentrations
25 min of dialysis
|
1.7 mmol/L
Standard Deviation 0.62
|
1.0 mmol/L
Standard Deviation 0.48
|
|
Peridialytic Venous Blood Acetate Concentrations
60 min of dialysis
|
1.6 mmol/L
Standard Deviation 0.60
|
1.0 mmol/L
Standard Deviation 0.52
|
|
Peridialytic Venous Blood Acetate Concentrations
90 min of dialysis
|
1.6 mmol/L
Standard Deviation 0.81
|
0.9 mmol/L
Standard Deviation 0.62
|
|
Peridialytic Venous Blood Acetate Concentrations
120 min of dialysis
|
2.0 mmol/L
Standard Deviation 0.74
|
1.0 mmol/L
Standard Deviation 0.82
|
|
Peridialytic Venous Blood Acetate Concentrations
150 min of dialysis
|
1.8 mmol/L
Standard Deviation 0.67
|
1.1 mmol/L
Standard Deviation 0.65
|
|
Peridialytic Venous Blood Acetate Concentrations
180 min of dialysis
|
1.8 mmol/L
Standard Deviation 0.70
|
1.1 mmol/L
Standard Deviation 0.76
|
Adverse Events
GranuFlo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NaturaLyte
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GranuFlo
n=10 participants at risk
The safety reporting group included subjects who received one study related hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo.
|
NaturaLyte
n=11 participants at risk
The safety reporting group included subjects who received one study related hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60