High Versus Low Bicarbonate Bath in Critically-ill Patients Receiving Continuous Renal Replacement Therapy

NCT ID: NCT03846258

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2024-04-01

Brief Summary

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).

Detailed Description

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.

Conditions

Metabolic Acidosis; Acute Kidney Injury; Acute Kidney Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low bicarbonate arm (22 mmol/L)

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.

Group Type: ACTIVE_COMPARATOR

Low bicarbonate solution (22 mmol/L)

Intervention Type: DRUG

Participants randomized to this arm will be started on CRRT using Phoxillum as the replacement fluid.

High Bicarbonate (32 mmol/L)

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.

Group Type: ACTIVE_COMPARATOR

High Bicarbonate solution (32 mmol/L)

Intervention Type: DRUG

Participants randomized to this arm will be started on CRRT using Prismasate as the replacement fluid.

Interventions

Low bicarbonate solution (22 mmol/L)

Participants randomized to this arm will be started on CRRT using Phoxillum as the replacement fluid.

Intervention Type: DRUG

High Bicarbonate solution (32 mmol/L)

Participants randomized to this arm will be started on CRRT using Prismasate as the replacement fluid.

Intervention Type: DRUG

Other Intervention Names

Phoxillum; Prismasate

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥ 18 years of age)
• Ability to obtain informed consent, either from patient or legally authorized representative (LAR)
• Diagnosis of AKI according to KDIGO definition [an increase in serum creatinine concentration of greater than or equal to 0.3 mg/dL within the first 48 hours of injury, a relative increase in serum creatinine of greater than or equal to 50% (1.5-fold from baseline) within the first 7 days of injury, or a reduction in urine output (<0.5 mL/kg/h for more than 6 hours)]
• CRRT initiated for the first time during current ICU admission.
• Bicarbonate ≤ 22 mEq/L
• Arterial pH between 7.05 and 7.25(if an ABG is not available, venous pH must be between 7.00 and 7.20)

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):

• INR >2
• AST/ALT more than 500 U/L and
• Bilirubin more than 12 mg/dL)
• Previous enrollment in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Kianoush B. Kashani

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kianoush B Kashani

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

18-010147

Identifier Type: -

Identifier Source: org_study_id