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

Phase 4

Withdrawn

• Conditions: Acute Kidney Injury; Metabolic Acidosis; Acute Kidney Failure
• Interventions: Drug: High Bicarbonate solution (32 mmol/L); Drug: Low bicarbonate solution (22 mmol/L)

• Registration Number: NCT03846258
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Study Start: 2019-05-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Bicarbonate (32 mmol/L)	High Bicarbonate solution (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.
Low bicarbonate arm (22 mmol/L)	Low bicarbonate solution (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.

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	120 days	Discharge status: death

Secondary Outcome Measures

Name	Time	Method
Time to achieve pH >7.3	30 days	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	120 Days	Composite outcome of death, persistent kidney dysfunction (creatinine more than 1.5 times baseline) or need for renal replacement therapy at specified time intervals.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States