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

Withdrawn before enrolling · Phase 4

Conditions studied: Metabolic Acidosis, Acute Kidney Injury, Acute Kidney Failure

In brief

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).

Key facts

Study ID

NCT03846258

Run by

Mayo Clinic

People needed

0

Starts

2019-05-01

Expected to finish

2024-04-01

Last updated by the study team

2021-04-28

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.