Critically ill patients with metabolic acidosis and acute kidney injury Nutritional, Metabolic, Endocrine Acidosis
Conditions
Interventions
For patients randomised to the intervention group, clinical staff will administer sodium bicarbonate 8.4% weight/volume intravenously, aiming to restore pH to >=7.30. The intervention will continue fo
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion 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* or • Serum creatinine =354 µmol/L, AND either a rise of =27 µmol/L within 48 hours or serum creatinine =1.5 times baseline* or • 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. • If there are multiple pre-hospitalisation values, then use the one closest to the date of the current hospital admission. • If a pre-hospitalisation value from the 365 days prior to admission date is not available and there are multiple serum creatinine values from the current hospitalisation, then use the lowest one from the current hospitalisation. • If no baseline serum creatinine value is available, then estimate it using the provided calculator. _____ Previous inclusion criteria: 1. Adult (aged =18 years) 2. Metabolic acidosis (defined by arterial blood gas values of pH <7.25, PaCO2 <6.5 kPa and bicarbonate =20 mmol/L) 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* or • Serum creatinine =354 µmol/L, AND either a rise of =27 µmol/L within 48 hours or serum creatinine =1.5 times baseline* or • 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. • If there are multiple pre-hospitalisation values, then use the one closest to the date of the current hospital admission. • If a pre-hospitalisation value from the 365 days prior to admission date is not available and there are multiple serum creatinine values from the current hospitalisation, then use the lowest one from the current hospitalisation as the baseline value. • If no baseline serum creatinine value is available, then estimate it using the provided calculator.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 16/01/2025: 1. Respiratory acidosis (acute or chronic) 2. Kidney replacement therapy (KRT) planned to start within 3 hours 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 eGFR150 mmol/L) † 12. Severe hypokalaemia (Potassium 150 mmol/L) † 12. Severe hypokalaemia (Potassium 150 mmol/l)† 12. Severe hypokalaemia (Potassium <3.0 mmol/l)† 13. Death perceived as imminent 14. Known hypersensitivity to sodium bicarbonate or to any of the excipients listed in section 6.1 of the SmPC 15. Previously randomised into MOSAICC † Exclusion criteria 10-12 are dynamic, and if corrected, the patient may be reconsidered for the trial. _____ Previous participant exclusion criteria as of 02/11/2021: 1. Respiratory acidosis (acute or chronic) 2. Clinical decision already in place to start the patient on kidney replacement therapy (KRT) 3. Deemed unsuitable for KRT 4. Acute diarrhoea, including high output stoma/ileostomy 5. Percutaneous biliary drainage 6. Documented Stage 4 chronic kidney disease (C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical effectiveness measured by all-cause mortality at 90 days following randomisation using patient records 2. Cost-effectiveness measured using incremental costs, QALYs, and net monetary benefit at 90 days following randomisation using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality at critical care unit discharge, 28 days and 1 year measured using patient records 2. Receipt and duration of respiratory, renal, and advanced cardiovascular organ support, defined according to the Critical Care Minimum Dataset (CCMDS), during the critical care stay measured using patient records 3. Duration of critical care unit and acute hospital stay measured using patient records 4. On-going requirement for KRT at 90 days and 1 year measured using patient records 5. HRQoL at 90 days and 1 year (assessed using the EQ-5D-5L questionnaire) 6. Resource use and costs at 90 days and 1 year measured using patient records 7. Estimated lifetime incremental cost-effectiveness based on the Health Services questionnaire, as well as resource use and costs at 90 days and 1 year and HRQoL | — |
Countries
England, United Kingdom
Contacts
Public ContactStudy Team
Outcome results
None listed