Multicentre evaluation of sodium bicarbonate in acute kidney injury in critical care (MOSAICC)

Phase 4

• Conditions: Critically ill patients with metabolic acidosis and acute kidney injury; Nutritional, Metabolic, Endocrine; Acidosis

• Registration Number: ISRCTN14027629
• Lead Sponsor: niversity Hospitals of Derby and Burton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-27
• Last Update Posted: 18 June 2024
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2250

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

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)
10. Symptomatic hypocalcaemia (Ionised calcium <1.05 mmol/L) †
11. Hypernatraemia (Plasma sodium >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, patient may be reconsidered for the trial.

_____

Previous participant exclusion criteria as of 28/04/2022:

1. Respiratory acidosis (acute or chronic)
2. Clinical decision already in place to start patient on kidney replacement therapy (KRT)
3. Deemed unsuitable for KRT
4. High output stoma/ileostomy
5. Percutaneous biliary drainage
6. Documented eGFR<15 ml/min/1.73 m² 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)
10. Symptomatic hypocalcaemia (Ionised calcium <1.05 mmol/l)†
11. Hypernatraemia (Plasma sodium >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 (CKD) [eGFR <30 ml/min/1.73m2] 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)
10. Known to be pregnant
11. Symptomatic hypocalcaemia (Ionised calcium <1.05 mmol/L)†
12. Hypernatraemia (Plasma sodium >150 mmol/L)†
13. Severe hypokalaemia (Potassium <3.0 mmol/L)†
14. Solid organ transplant
15. Death perceived as imminent
16. Known hypersensitivity to sodium bicarbonate or to any of the excipients listed in section 6.1 of the SmPC
†Exclusion criteria 11-13 are dynamic, and if corrected, the patient may be reconsidered for the trial

Previous exclusion criteria:
1. Respiratory acidosis (acute or chronic)
2. Clinical decision already in place to start the patient on kidney replacement therapy (KRT)
3. Acute diarrhoea, including high output stoma/ileostomy
4. Percutaneous biliary drainage
5. Documented stage 4 chronic kidney disease (CKD) [eGFR <30ml/min/1.73m²] or end-stage kidney disease (ESKD) on dialysis
6. Known renal tubular acid

Study & Design

• Study Type: Interventional
• Study Design: Not specified