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

Primary Purpose

Metabolic Acidosis, Acute Kidney Injury, Acute Kidney Failure

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Low bicarbonate solution (22 mmol/L)

High Bicarbonate solution (32 mmol/L)

About this trial

This is an interventional treatment trial for Metabolic Acidosis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Low bicarbonate arm (22 mmol/L)

High Bicarbonate (32 mmol/L)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

In-hospital mortality

Discharge status: death

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT03846258

First Posted

February 14, 2019

Last Updated

April 26, 2021

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03846258

Brief Title

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

Official Title

High Versus Low Bicarbonate Bath in Critically-ill Patients Receiving Continuous Renal Replacement Therapy: a Pragmatic Randomized Control Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Withdrawn

Why Stopped

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.

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

April 1, 2024 (Anticipated)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Acidosis, Acute Kidney Injury, Acute Kidney Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low bicarbonate arm (22 mmol/L)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

High Bicarbonate (32 mmol/L)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Low bicarbonate solution (22 mmol/L)

Other Intervention Name(s)

Phoxillum

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

High Bicarbonate solution (32 mmol/L)

Other Intervention Name(s)

Prismasate

Intervention Description

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

Primary Outcome Measure Information:

Title

In-hospital mortality

Description

Discharge status: death

Time Frame

120 days

Secondary Outcome Measure Information:

Title

Time to achieve pH >7.3

Description

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

Time Frame

30 days

Title

Major Adverse Kidney events

Description

Composite outcome of death, persistent kidney dysfunction (creatinine more than 1.5 times baseline) or need for renal replacement therapy at specified time intervals.

Time Frame

120 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kianoush B Kashani

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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