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SODium BICarbonate for Metabolic Acidosis in the ICU

PHASE3ACTIVE_NOT_RECRUITING

This trial aims to assess if, among adults in the ICU with metabolic acidosis, an infusion of sodium bicarbonate diluted in 5% dextrose, compared with an infusion of 5% dextrose, reduces Major Adverse Kidney Events within 30 days of randomization.

Study details:

Background: Metabolic acidosis refers to any process that elevates the concentration of hydrogen ions in the body, and is commonly encountered in critical illness. Lactic acidosis, diabetic ketoacidosis, and hyperchloremic acidosis are major examples seen in the intensive care unit (ICU). Metabolic acidosis may impair cardiac function, and sodium bicarbonate can be used to normalise blood pH.

Despite being in common clinical usage, the clinical efficacy of sodium bicarbonate is still uncertain. Previous studies exploring the effects of sodium bicarbonate therapy have been limited and of variable quality. Aim: This trial aims to assess if, among adults in the ICU with metabolic acidosis, an infusion of sodium bicarbonate diluted in 5% dextrose, compared with an infusion of 5% dextrose, reduces Major Adverse Kidney Events within 30 days of randomization.

Study Design: Phase 3, international, multicentre, double-blind, randomised clinical trial. Participants: Adult patients (≥ 18 years old), admitted to the ICU within 48 hours, receiving a continuous infusion of a vasopressor drug to maintain a mean arterial pressure \> 65 mmHg (or a mean arterial pressure target set by the treating clinician), a dedicated line (central or peripheral) is available (or is about to be made available within 1 hour after randomisation), and within two hours prior to randomisation the participant has metabolic acidosis, defined as: 1) pH \< 7. 30; 2) BE ≤ -4 mEq/L; and 3) PaCO2 ≤ 45 mmHg for non-intubated patients or PaCO2 ≤ 50 mmHg for non-intubated patients.

Intervention: Patients will be randomly allocated in a 1:1 ratio to receive two treatments that are commonly used either an infusion of 5% dextrose (D5W) + sodium bicarbonate, or D5W alone, as a comparator. Study drug will be continuously infused targeting a pH 7. 30 - 7.

35 and a BE ≥ 0 mEq/L. The infusion will be maintained until this target is achieved and continued by titration thereafter for a maximum of 5 hours (to maintain target pH and base excess levels). All other aspects of care will be determined by the treating clinical team, including the use of additional fluid therapy, vasopressors, and other organ support modalities.

Open-label sodium bicarbonate bolus infusion is allowed in both groups if clinically indicated. Primary outcome: The primary outcome is the proportion of patients who meet one or more criteria for a major adverse kidney event within 30 days (MAKE 30). MAKE 30 is a composite of death, new receipt of renal-replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥ 200% of the baseline value).

All components of MAKE30 will be censored at hospital discharge or 30 days after enrolment, whichever comes first.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Adults (≥ 18 years)
  2. Receiving a continuous infusion of a vasopressor to maintain mean arterial pressure > 65 mmHg (or a mean arterial pressure target set by the treating clinician)
  3. A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour)
  4. Metabolic acidosis, defined as:
  5. pH < 7.30
  6. BE ≤ -4 mEq/L
  7. PaCO2 ≤ 45 mmHg for non-intubated patients or PaCO2 ≤ 50 mmHg for intubated patients

Exclusion criteria

  1. Fulfilled all eligibility criteria greater than 48 hours ago
  2. Suspected clinically significant digestive or urinary tract loss of sodium bicarbonate (e.g., diarrhoea, ileostomy losses, renal tubular acidosis, or drainage of pancreatic or bile duct)
  3. DKA
  4. Estimated glomerular filtration rate (eGFR) < 30 mL/min due to chronic kidney disease
  5. Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed)
  6. Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team)
  7. Severe dysnatraemia (serum Na ≥ 155 mEq/L or < 120 mEq/L)
  8. Hypokalaemia (serum K < 2.5 mEq/L)
  9. Pulmonary oedema with PaO2 / FiO2 < 100
  10. Hypocalcaemia (iCa < 0.8mmol/L)
  11. Patients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication)
  12. Pregnancy or breastfeeding
  13. Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient or the substitute decision maker are not committed to full active treatment
  14. Patients with a life expectancy < 30 days due to a chronic or underlying medical condition
  15. Considered to be at high risk of cerebral oedema by the treating clinician (e.g. traumatic brain injury or acute brain disease)
  16. Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient
  17. Previous enrolment in this study

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study ID

NCT05697770

Intervention or treatment

DRUG: Sodium bicarbonate

DRUG: 5% Dextrose

Conditions

  • Metabolic Acidosis
  • Shock

  • Condition: Metabolic Acidosis, Shock

  • DRUG: Sodium bicarbonate and other drugs

  • Garran, Australian Capital Territory, Australia and more

  • Sponsor: Australian and New Zealand Intensive Care Research Centre

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Are you running this trial?

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Research sites nearby

Closest Location:

Canberra Hospital

Select from list below to view details:

  • Canberra Hospital

    Garran, Australian Capital Territory, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, Australia

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, Australia

  • Gosford Hospital

    Gosford, New South Wales, Australia

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Who is running the clinical trial?

AaNZICRC

Australian and New Zealand Intensive Care Research Centre

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Sodium bicarbonate
  • Sodium bicarbonate 8.4% (1000 mEq/L) will be diluted in a D5W solution (500 mL bag). For preparation, 300 mL of D5W will be removed and 300 mL of sodium bicarbonate 8.4% added to prepare the bicarbonate solution in a total volume of 500 mL (final concentration: 600 mEq/L).
Drug: Sodium bicarbonate
    ACTIVE_COMPARATOR: 5% dextrose
    • Standard 500 mL bag of D5W.
    Drug: 5% Dextrose

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      MAKE30 scoreThe primary outcome is MAKE30 from the date of randomisation. MAKE30 is defined as a composite of death from any cause, receipt of RRT, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline), all censored at hospital discharge or 30 days, whichever occurs first.30 days or at hospital discharge (whichever occurs first)

      Secondary Outcome

      MeasureDescriptionTime Frame
      30-day in-hospital mortalityAll-cause in-hospital mortality at day 3030 days or at hospital discharge (whichever occurs first)
      Receipt of renal replacement therapy in the first 30 daysReceipt of renal replacement therapy in the first 30 days30 days or at hospital discharge (whichever occurs first)
      Persistent renal dysfunctionDefined as an elevation of the creatinine level to ≥ 200% of baseline30 days or at hospital discharge (whichever occurs first)
      Renal replacement therapy dependence at day 30Defined by the receipt of any form of renal replacement therapy within ± 10 days of the 30-day time point following randomisation30 days or at hospital discharge (whichever occurs first)
      ICU mortalityAll-cause ICU mortality at day 3030 days or at hospital discharge (whichever occurs first)
      Hospital mortalityAll-cause hospital mortality at day 9090 days or at hospital discharge (whichever occurs first)
      90-day in-hospital mortalityAll-cause mortality at day 9090 days or at hospital discharge (whichever occurs first)
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: SODium BICarbonate for Metabolic Acidosis in the ICU

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