Status:
WITHDRAWN
High Versus Low Bicarbonate Bath in Critically-ill Patients Receiving Continuous Renal Replacement Therapy
Lead Sponsor:
Mayo Clinic
Conditions:
Metabolic Acidosis
Acute Kidney Injury
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
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 failu...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03846258
Start Date
May 1 2019
End Date
April 1 2024
Last Update
April 28 2021
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905