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This study is a prospective, single center, single blind (patient and laboratory), randomized, cross-over, two week investigation of intradialytic acid-base kinetics and physiology associated with use of two commercial acid dialysate concentrates in prevalent hemodialysis patients.
Approximately 10-20 prevalent hemodialysis patients will be recruited. Subjects will randomized to receive one weekly hemodialysis treatment using each of the two acetate acid dialysate buffers of NaturaLyte and GranuFlo, which will be assigned in a random fashion. Acetate and bicarbonate concentrations will be assessed before, at eight time points during, and six time points after the completion of hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: GranuFlo | Active Comparator | 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: blood and dialysate samples will be obtained at specific time points during the dialysis treatments. |
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| Group 2: NaturaLyte | Active Comparator | 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: blood and dialysate samples will be obtained at specific time points during the dialysis treatments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1: GranuFlo | Device | 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: blood and dialysate samples will be obtained at specific time points during the dialysis treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Peridialytic Arterialized Blood Bicarbonate Concentrations | Quantification of Peridialytic Arterialized Blood Bicarbonate Concentrations | 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 |
| Peridialytic Venous Blood Bicarbonate Concentrations | Quantification of Peridialytic Venous Blood Bicarbonate Concentrations | 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis |
| Peridialytic Arterialized Blood Acetate Concentrations | Quantification of Peridialytic Arterialized Blood Acetate Concentrations | 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 |
| Peridialytic Venous Blood Acetate Concentrations | Quantification of Peridialytic Venous Blood Acetate Concentrations | 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis |
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Inclusion Criteria:
Subjects eligible to be entered into this study will meet all of the following criteria:
Exclusion Criteria:
Patients that meet any of the following criteria will be ineligible for this study:
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| Name | Affiliation | Role |
|---|---|---|
| William B Smith, MD | Volunteer Research Group and New Orleans Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Volunteer Research Group and New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28851317 | Derived | Smith WB, Gibson S, Newman GE, Hendon KS, Askelson M, Zhao J, Hantash J, Flanagan B, Larkin JW, Usvyat LA, Thadhani RI, Maddux FW. The dynamics of the metabolism of acetate and bicarbonate associated with use of hemodialysates in the ABChD trial: a phase IV, prospective, single center, single blind, randomized, cross-over, two week investigation. BMC Nephrol. 2017 Aug 29;18(1):273. doi: 10.1186/s12882-017-0683-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1Week 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peridialytic Arterialized Blood Bicarbonate Concentrations | Quantification of Peridialytic Arterialized Blood Bicarbonate Concentrations | Per Protocol Population | Posted | Mean | Standard Deviation | mEq/l | 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 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GranuFlo | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brigid Flanagan, MS, RN, CCRC | Frenova Renal Research | 781-699-2970 | Brigid.Flanagan@frenovarenalresearch.com |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Group 2: NaturaLyte | Device | 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: blood and dialysate samples will be obtained at specific time points during the dialysis treatments. |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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
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| Primary | Peridialytic Venous Blood Bicarbonate Concentrations | Quantification of Peridialytic Venous Blood Bicarbonate Concentrations | Per Protocol Population | Posted | Mean | Standard Deviation | mEq/l | 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis |
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| Primary | Peridialytic Arterialized Blood Acetate Concentrations | Quantification of Peridialytic Arterialized Blood Acetate Concentrations | Per Protocol Population | Posted | Mean | Standard Deviation | mmol/L | 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 |
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| Primary | Peridialytic Venous Blood Acetate Concentrations | Quantification of Peridialytic Venous Blood Acetate Concentrations | Per Protocol Population | Posted | Mean | Standard Deviation | mmol/L | 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis |
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| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | NaturaLyte | 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. | 0 | 11 | 1 | 11 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 90 min of dialysis |
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| 120 min of dialysis |
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| 150 min of dialysis |
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| 180 min of dialysis |
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| 210 min of dialysis |
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| 240 min of dialysis |
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| 60 min of dialysis |
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| 90 min of dialysis |
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| 120 min of dialysis |
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| 150 min of dialysis |
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| 180 min of dialysis |
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| 210 min of dialysis |
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| 240 min of dialysis |
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| 15 min post-dialysis |
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| 30 min post-dialysis |
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| 45 min post-dialysis |
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| 60 min post-dialysis |
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| 75 min post-dialysis |
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| 90 min post-dialysis |
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| 90 min of dialysis |
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| 120 min of dialysis |
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| 150 min of dialysis |
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| 180 min of dialysis |
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| 210 min of dialysis |
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| 240 min of dialysis |
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