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Due to the fact that we were unable to find subjects who met all inclusion and exclusion criteria it was determined to withdraw this study.
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Researchers are trying to determine which dialysis solution, low bicarbonate fluid (22 mmol/L) or high bicarbonate fluid (32 mmol/L), is better in subjects with acute kidney injury (acute kidney failure) and metabolic acidosis that are admitted to the intensive care unit and require continuous renal replacement therapy (also known as continuous dialysis).
This is a prospective randomized trial that will be conducted at Mayo Clinic in Rochester Minnesota. It will be based on Good Clinical Practice Standards and performed under IRB supervision. This will be a pragmatic clinical trial due to the nature of the intervention and short interval for making a clinical decision. While dialysis in general is valid in cases of severe AKI and metabolic acidosis, there remains uncertainty as to which replacement fluid to use. In one retrospective study, using high bicarbonate replacement fluid was associated with worse outcomes, even after accounting for several important confounders. While this intervention is valid in cases of severe metabolic acidosis (pH<7), there has not been much data to support the use of either intervention in cases of any metabolic acidosis in general.
While both interventions are equally valid, to our knowledge, there is no randomized clinical trial evaluating the difference of either intervention on outcomes. There is limited evidence in the literature on benefit or harm associated with either of the interventions on the outcomes thus generating a clinical equipoise. This pivotal study should help guide nephrologists and intensivists on the appropriate prescription of CRRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low bicarbonate arm (22 mmol/L) | Active Comparator | PHOXILLUM solutions are used as a replacement solution in Continuous Renal Replacement Therapy. The one to be used in this study has bicarbonate concentration of 22 mmol/L. |
|
| High Bicarbonate (32 mmol/L) | Active Comparator | PrismaSATE is another replacement solution used in Continuous Renal Replacement Therapy. The one to be used in this study has bicarbonate concentration of 32 mmol/L. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low bicarbonate solution (22 mmol/L) | Drug | Participants randomized to this arm will be started on CRRT using Phoxillum as the replacement fluid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | Discharge status: death | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve pH >7.3 | The number of hours it took each participant to have an arterial pH of >7.3 or a venous pH > 7.35 following CRRT initiation | 30 days |
| Major Adverse Kidney events | Composite outcome of death, persistent kidney dysfunction (creatinine more than 1.5 times baseline) or need for renal replacement therapy at specified time intervals. |
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Inclusion Criteria
Exclusion Criteria
Pregnancy (women of child-bearing potential must have a negative pregnancy test)
Diagnosis of End-Stage renal disease and receiving Hemodialysis or peritoneal dialysis prior to ICU admission (this information will be easily obtained by the nephrology team)
Arterial pH <7.05 or >7.25 (if an ABG is not available, Venous pH <7.00 or >7.20)
Potassium level >6.0 mmol/L
Severe acute liver failure meeting all the following criteria):
Previous enrollment in this study
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| Name | Affiliation | Role |
|---|---|---|
| Kianoush B Kashani | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| High Bicarbonate solution (32 mmol/L) | Drug | Participants randomized to this arm will be started on CRRT using Prismasate as the replacement fluid. |
|
|
| 120 Days |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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