critical care studies summaries

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Protocol v4.3 05/04/2024
Rotherham Principal Investigator: Professor Anil Hormis


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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

what to document:

This patient has been entered into a research trial:
Trial name: MOSAICC – Evaluating the clinical and cost effectiveness of Sodium Bicarbonate administration for critically ill patients with Acute Kidney Injury and metabolic acidosis
Local study ref. no: 21-08-09
Principal Investigator: Prof Anil Hormis 8334
[Patient Name] met all inclusion and no exclusion for the MOSAICC trial at [Date/Time]. Eligibility confirmed with Dr [XXX]. Randomisation performed by online website by [Staff Name].
[copy and paste the randomisation : date/time/trial ID number/randomisation allocation]
Select as appropriate:
IF INTERVENTION: When pH <7.3, intravenous sodium bicarbonate 8.4% w/v should be administered according to the trial dosage schedule, up to a maximum daily dose of 500 ml/24 hours.
OR
IF CONTROL: Patients should not receive intravenous sodium bicarbonate. All other care will be provided at the discretion of the treating clinical team according to local routine practice.
Consent note: [Patient Name] lacks mental capacity to approach for consent. Patient was entered into trial prior to consent as per approved trial protocol. Personal/Professional Legal Representative will be approached as soon as possible.
[if does have capacity comment on the extent it was explained/they agreed to – formal consent can still be sought afterwards when recovered from critical illness]
 
For full protocol details of trial can be found in research office DLE91 PGME Corridor or contact 6060.
Any questions please contact Cheryl Graham, Clinical Research Nurse, 6060.