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

• Status: Withdrawn
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Pharmaceutical Solutions

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