SODium BICarbonate for Metabolic Acidosis in the ICU

NCT05697770 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: ANZIC-RC/ASN001
• Study Type: interventional
• Target: 500
• Locations: 7 countries
• Sites: 55

Brief Summary

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.

Conditions

Shock; Metabolic Acidosis

Keywords

Sodium bicarbonate; Metabolic acidosis; Shock; Clinical trial

Outcome Measures

Primary Outcomes (1)

• MAKE30 score

  The 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 Outcomes (7)

• 30-day in-hospital mortality

  30 days or at hospital discharge (whichever occurs first)

• Receipt of renal replacement therapy in the first 30 days

  30 days or at hospital discharge (whichever occurs first)

• Persistent renal dysfunction

  30 days or at hospital discharge (whichever occurs first)

• Renal replacement therapy dependence at day 30

  30 days or at hospital discharge (whichever occurs first)

• ICU mortality

  30 days or at hospital discharge (whichever occurs first)

Other Outcomes (7)

• Recurrence of metabolic acidosis in the first 7 days after randomization

  7 days after randomization

• Incidence and the maximum stage of AKI in the first 7 days after randomization

  7 days after randomization

• Vasopressor-free days at day 30

  30 days or at hospital discharge (whichever occurs first)

Study Arms (2)

Sodium bicarbonate

EXPERIMENTAL

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

5% dextrose

ACTIVE COMPARATOR

Standard 500 mL bag of D5W.

Drug: 5% Dextrose

Interventions

Sodium bicarbonate DRUG

Sodium bicarbonate 8.4% will be continuously infused for a maximum of 5 hours. The infusion will start at 100 mL/hr and be kept at this rate until both pH and BE targets are achieved, following which, the infusion rate will be decreased to 25 mL/hr and kept constant at this rate until 5 hours has elapsed since the start of the infusion. At this point, the infusion will be stopped, independently, of the results of arterial blood gas analysis.

Sodium bicarbonate

5% Dextrose DRUG

5% dextrose will be continuously infused for a maximum of 5 hours. The infusion will start at 100 mL/hr and be kept at this rate until both pH and BE targets are achieved, following which, the infusion rate will be decreased to 25 mL/hr and kept constant at this rate until 5 hours has elapsed since the start of the infusion. At this point, the infusion will be stopped, independently, of the results of arterial blood gas analysis.

5% dextrose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All the diagnostic criteria of metabolic acidosis below have to be fulfilled within the last 2 hours before randomisation (pH, PaCO2 and BE from the same blood gas), and a vasopressor is being infused continuously at the time of randomization.
• Adults (≥ 18 years);
• 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);
• A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour); and
• Metabolic acidosis, defined as:
• pH \< 7.30; and
• BE ≤ -4 mEq/L; and
• PaCO2 ≤ 45 mmHg for non-intubated patients or PaCO2 ≤ 50 mmHg for intubated patients.

You may not qualify if:

• Fulfilled all eligibility criteria greater than 48 hours ago; or
• 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); or
• DKA; or
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min due to chronic kidney disease; or
• Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed); or
• Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team); or
• Severe dysnatraemia (serum Na ≥ 155 mEq/L or \< 120 mEq/L); or
• Hypokalaemia (serum K \< 2.5 mEq/L); or
• Pulmonary oedema with PaO2 / FiO2 \< 100; or
• Hypocalcaemia (iCa \< 0.8mmol/L); or
• Patients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication); or
• Pregnancy or breastfeeding; or
• 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; or
• Patients with a life expectancy \< 30 days due to a chronic or underlying medical condition; or
• Considered to be at high risk of cerebral oedema by the treating clinician (e.g. traumatic brain injury or acute brain disease); or

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead

Study Sites (55)

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Sutherland Hospital

Caringbah, New South Wales, 2229, Australia

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Gosford Hospital

Gosford, New South Wales, 2250, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

Orange Health Service

Orange, New South Wales, 2800, Australia

Location

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

Location

Sydney Adventist Hospital

Wahroonga, New South Wales, 2076, Australia

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Royal Darwin Hospital

Tiwi, Northern Territory, 0810, Australia

Location

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

Cairns Hospital

Cairns, Queensland, 4870, Australia

Location

Queen Elizabeth II Jubilee Hospital

Coopers Plains, Queensland, 4108, Australia

Location

Townsville University Hospital

Douglas, Queensland, 4814, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4006, Australia

Location

Ipswich Hospital

Ipswich, Queensland, 4305, Australia

Location

Mater Hospital

South Brisbane, Queensland, 4101, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Princess Alexandra Hopsital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, Australia

Location

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

Location

The Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

Grapmians Health

Ballarat, Victoria, 3350, Australia

Location

Bendigo Hospital

Bendigo, Victoria, 3550, Australia

Location

Casey Hospital

Berwick, Victoria, 3806, Australia

Location

The Victorian Heart Hospital

Clayton, Victoria, 3065, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Dandenong Hospital

Dandenong, Victoria, 3175, Australia

Location

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Footscray Hospital

Footscray, Victoria, 3011, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

University Hospital Geelong

Geelong, Victoria, 3220, Australia

Location

The Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Peninsula Private Hospital

Langwarrin, Victoria, 3910, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Epworth

Richmond, Victoria, 3121, Australia

Location

Sunshine Hospital

St Albans, Victoria, 3021, Australia

Location

Bunbury Regional Hospital

Bunbury, Western Australia, 6230, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Centro de Estudos e de Pesquisas em Terapia Intensiva

Curitiba, Paraná, 82530-200, Brazil

Location

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, Puducherry, 605006, India

Location

Deep Hospital

Ludhiana, Punjab, 141002, India

Location

The Jikei University Hospital

Minato, Tokyo, 105-0003, Japan

Location

Auckland City Hospital (CVICU)

Auckland, Auckland, 1023, New Zealand

Location

Auckland City Hospital (DCCM)

Auckland, Auckland, 1023, New Zealand

Location

Middlemore Hospital

Auckland, Auckland, 2025, New Zealand

Location

Christchurch Hospital

Christchurch, Christchurch, 4710, New Zealand

Location

Dunedin Hospital

Dunedin, Dunedin, 9016, New Zealand

Location

Waikato Hospital

Hamilton, Hamilton, 3204, New Zealand

Location

Rotorua Hospital

Rotorua, Rotorua, 3010, New Zealand

Location

Wellington Regional Hospital

Wellington, New Zealand

Location

Sultan Qaboos Comprehensive Cancer Care and Research Center

Seeb, Oman

Location

King Abdullah International Medical Research Center

Riyadh, Riyadh Region, 11481, Saudi Arabia

Location

Related Publications (1)

• Serpa Neto A, McNamara M, Cooper J, Fujii T, Higgins A, Hodgson C, Navarra L, Nichol A, Peake S, Rea-Neto A, Secombe P, See E, Taylor P, Young M, Zampieri FG, Young P, Bellomo R, Udy A; SODa-BIC investigators. Protocol summary and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial. Crit Care Resusc. 2025 May 15;27(2):100108. doi: 10.1016/j.ccrj.2025.100108. eCollection 2025 Jun.

  PMID: 40487345 DERIVED

MeSH Terms

Conditions

Acidosis; Shock

Interventions

Sodium Bicarbonate; Glucose

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Ary Serpa Neto, PhD

  ANZIC RC, Monash university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An unblinded research coordinator, pharmacist or nurse not involved in data collection or bedside care will prepare the drug. The bedside nurse who administers the drug, other care providers, all investigators and outcome assessors will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly allocated in a 1:1 ratio to receive either an infusion of D5W + sodium bicarbonate, or D5W alone.

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: January 26, 2023
• Study Start: April 26, 2023
• Primary Completion: January 8, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1); NZ (8); IN (2); OM (1); AU (41); JP (1); BR (1)