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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03846258
Other study ID # 18-010147
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date May 1, 2019
Est. completion date April 1, 2024

Study information

Verified date April 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Intervention

Drug:
Low bicarbonate solution (22 mmol/L)
Participants randomized to this arm will be started on CRRT using Phoxillum as the replacement fluid.
High Bicarbonate solution (32 mmol/L)
Participants randomized to this arm will be started on CRRT using Prismasate as the replacement fluid.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary In-hospital mortality Discharge status: death 120 days
Secondary 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
Secondary 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. 120 Days
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