ISRCTN14027629
Active, not recruiting
Phase 4
Evaluating the clinical and cost-effectiveness of sodium bicarbonate administration for critically ill patients with acute kidney injury and metabolic acidosis
niversity Hospitals of Derby and Burton NHS Foundation Trust0 sites2,250 target enrollmentJuly 27, 2021
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospitals of Derby and Burton NHS Foundation Trust
- Enrollment
- 2250
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 19/12/2022:
- •1\. Adult (aged \=18 years)
- •2\. Metabolic acidosis (defined by arterial blood gas values of pH \<7\.30 and PaCO2 \<6\.5 kPa)
- •3\. AKI – categorised as stage 2 or 3 of the Kidney Disease Improving: Global Outcomes (KDIGO) classification, defined as any one of the following three criteria:
- •Serum creatinine \=2\.0 times baseline\*
- •Serum creatinine \=354 µmol/L, AND
- •either a rise of \=27 µmol/L within 48 hours or serum creatinine \=1\.5 times baseline\*
- •Urine output of \<0\.5 ml/kg/h for \=12 hours
- •\*For baseline serum creatinine value:
- •If available, then use pre\-hospitalisation value within 365 days of the current hospital admission date.
Exclusion Criteria
- •Current exclusion criteria as of 19/12/2022:
- •1\. Respiratory acidosis (acute or chronic)
- •2\. Kidney replacement therapy (KRT) immediately indicated and treating clinician(s) unwilling to defer if randomised to sodium bicarbonate
- •3\. Deemed unsuitable for KRT
- •4\. High output stoma/ileostomy
- •5\. Percutaneous biliary drainage
- •6\. End stage kidney failure defined as documented eGFR\<15 ml/min/1\.73m² prior to onset of this acute illness or end stage kidney disease (ESKD) on dialysis
- •7\. Known renal tubular acidosis
- •8\. Diabetic ketoacidosis
- •9\. High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol)
Outcomes
Primary Outcomes
Not specified
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