anaesthetic & critical care studies summaries

---

Protocol v4.3 05/04/2024
Rotherham Principal Investigator: Professor Anil Hormis
Research team members: Cheryl Graham/Dr Katie Webb


​

research topic:

Use of Sodium Bicarbonate in AKI and metabolic acidosis in the critically ill

trial groups:

Intervention: 8.4% IV Sodium Bicarbonate given as per research protocol
Control: No IV Sodium Bicarbonate

inclusion criteria:

• Adult (aged ≥18 years)
• Metabolic acidosis (defined by arterial blood gas values of pH <7.30 and PaCO2 <6.5 kPa
• AKI – KDIGO stage 2 or 3, 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 but prior to the onset of this acute illness, then use the lowest one from the current hospitalisation.
• If no baseline serum creatinine value is available from prior to the onset of this acute illness, then estimate it using the provided calculator.

exclusion criteria:

• Respiratory acidosis (acute or chronic)
  
• Kidney replacement therapy (KRT) immediately indicated and treating clinician(s) unwilling to defer if randomised to sodium bicarbonate
• Deemed unsuitable for KRT
• High output stoma/ileostomy
• Percutaneous biliary drainage
• End stage kidney failure defined as documented eGFR <15ml/min/1.73m² prior to onset of this acute illness or end stage kidney disease (ESKD) on dialysis
  
•  Known renal tubular acidosis
• Diabetic ketoacidosis
• High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol)
• Symptomatic hypocalcaemia (Ionised calcium <1.05 mmol/L) †
• Hypernatraemia (Plasma sodium >150 mmol/L) †
• Severe hypokalaemia (Potassium <3.0 mmol/L) †
• Death perceived as imminent
• Known hypersensitivity to sodium bicarbonate or to any of the excipients
• Previously randomised into MOSAICC

randomisation:

Patients eligible for MOSAICC can be randomised straight away without consent required at the time of randomisation (unless you deem they have full capacity to understand and consent to the trial in the required time frame).
Sealed envelope website - https://www.sealedenvelope.com/access/
Login email: [email protected]
Password: UK-ROXROTH

running the intervention:

​The intervention can be prescribed be finding the prescription ‘set’ for clinical trials and selecting MOSAICC. Please ensure the frequency is PRN.
50mls of 8.4% IV Sodium Bicarbonate (usually given centrally over 30-60mins) for a pH <7.3, give the first straight away, re-check ABG 1-2 hours later. If pH <7.3 repeat the process. Can have up until 500mls in 24 hours.
The trial intervention will continue until discharge from critical care, initiation of KRT or 90 days, whichever comes first.

eligibility and randomisation training:

GCP is not required for eligibility and randomisation.

You could be randomising patients onto MOSAICC after covering eligibility and randomisation training, and signing the study training log and delegation log.