A Study to Compare High Versus Low Bicarbonate Bath in Critically-ill Patients Receiving Continuous Renal Replacement Therapy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-010147
NCT ID: NCT03846258
Sponsor Protocol Number: 18-010147
About this study
The purpose of this study is to investigate the effect of using high versus low bicarbonate containing replacement fluid in patients with metabolic acidosis receiving continuous renal replacement therapy (CRRT) with veno-venous hemofiltration (CVVH) for acute kidney injury (AKI) on in-hospital mortality.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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), or have received renal replacement therapy (either HD or CRRT) during the current hospital admission.
- 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 any of the following criteria:
- INR > 2;
- AST > 500 U/L;
- ALT > 500 U/L;
- Bilirubin > 12 mg/dL.
- Previous enrollment in this study.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available