Metabolic AcidosisPhase 3SODa-BICNCT05697770
SODium BICarbonate for Metabolic Acidosis in the ICU
A Phase 3 study testing Sodium bicarbonate and 5% Dextrose in people with Metabolic Acidosis and Shock, run by Australian and New Zealand Intensive Care Research Centre at 55 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Acidosis, Shock
- What is being tested?
- Sodium bicarbonate and 5% Dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 55 sitesin 7 countries
- Study dates
- 26 Apr 2023to Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
- Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; or
- Previous enrolment in this study.
Trial locations and contacts
55 sites in 7 countries.
55 sites in 7 countries
Australia41 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Grapmians Health
Ballarat, Victoria, 3350
Flinders Medical Centre
Bedford Park, South Australia
Bendigo Hospital
Bendigo, Victoria, 3550
Casey Hospital
Berwick, Victoria, 3806
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Bunbury Regional Hospital
Bunbury, Western Australia, 6230
Cairns Hospital
Cairns, Queensland, 4870
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Sutherland Hospital
Caringbah, New South Wales, 2229
The Victorian Heart Hospital
Clayton, Victoria, 3065
Monash Medical Centre
Clayton, Victoria, 3168
Queen Elizabeth II Jubilee Hospital
Coopers Plains, Queensland, 4108
Dandenong Hospital
Dandenong, Victoria, 3175
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Townsville University Hospital
Douglas, Queensland, 4814
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Footscray Hospital
Footscray, Victoria, 3011
Frankston Hospital
Frankston, Victoria, 3199
Canberra Hospital
Garran, Australian Capital Territory, 2605
University Hospital Geelong
Geelong, Victoria, 3220
Gosford Hospital
Gosford, New South Wales, 2250
The Austin Hospital
Heidelberg, Victoria, 3084
Royal Brisbane and Women's Hospital
Herston, Queensland, 4006
Ipswich Hospital
Ipswich, Queensland, 4305
Nepean Hospital
Kingswood, New South Wales, 2747
Peninsula Private Hospital
Langwarrin, Victoria, 3910
The Alfred Hospital
Melbourne, Victoria, 3004
Orange Health Service
Orange, New South Wales, 2800
Royal Perth Hospital
Perth, Western Australia, 6000
Epworth
Richmond, Victoria, 3121
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
Mater Hospital
South Brisbane, Queensland, 4101
Gold Coast University Hospital
Southport, Queensland, 4215
Sunshine Hospital
St Albans, Victoria, 3021
Royal Darwin Hospital
Tiwi, Northern Territory, 0810
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076
Calvary Mater Newcastle
Waratah, New South Wales, 2298
The Queen Elizabeth Hospital
Woodville, South Australia, 5011
Princess Alexandra Hopsital
Woolloongabba, Queensland, 4102
New Zealand8 sites
Auckland City Hospital (CVICU)
Auckland, Auckland, 1023
Auckland City Hospital (DCCM)
Auckland, Auckland, 1023
Middlemore Hospital
Auckland, Auckland, 2025
Christchurch Hospital
Christchurch, Christchurch, 4710
Dunedin Hospital
Dunedin, Dunedin, 9016
Waikato Hospital
Hamilton, Hamilton, 3204
Rotorua Hospital
Rotorua, Rotorua, 3010
Wellington Regional Hospital
Wellington
India2 sites
Deep Hospital
Ludhiana, Punjab, 141002
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, Puducherry, 605006
Brazil1 site
Centro de Estudos e de Pesquisas em Terapia Intensiva
Curitiba, Paraná, 82530-200
Saudi Arabia1 site
King Abdullah International Medical Research Center
Riyadh, Riyadh Region, 11481
About this study
Official title: SODium BICarbonate for Metabolic Acidosis in the Intensive Care Unit (SODa-BIC): A Multicentre, Randomised, Double-blind Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Metabolic Acidosis, Shock
- Being tested
- Sodium bicarbonate, 5% Dextrose
- Keywords
- Sodium bicarbonate, Metabolic acidosis, Shock, Clinical trial
- Medical subject headings
- Acidosis, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
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.
5% DextroseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Sodium bicarbonate |
| 5% dextrose | Active comparator | Standard 500 mL bag of D5W. Receives: Drug: 5% Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days or at hospital discharge (whichever occurs first)
Secondary outcomes (7)
30-day in-hospital mortality
All-cause in-hospital mortality at day 30
Measured: 30 days or at hospital discharge (whichever occurs first)
Receipt of renal replacement therapy in the first 30 days
Receipt of renal replacement therapy in the first 30 days
Measured: 30 days or at hospital discharge (whichever occurs first)
Persistent renal dysfunction
Defined as an elevation of the creatinine level to ≥ 200% of baseline
Measured: 30 days or at hospital discharge (whichever occurs first)
Renal replacement therapy dependence at day 30
Defined by the receipt of any form of renal replacement therapy within ± 10 days of the 30-day time point following randomisation
Measured: 30 days or at hospital discharge (whichever occurs first)
ICU mortality
All-cause ICU mortality at day 30
Measured: 30 days or at hospital discharge (whichever occurs first)
Hospital mortality
All-cause hospital mortality at day 90
Measured: 90 days or at hospital discharge (whichever occurs first)
90-day in-hospital mortality
All-cause mortality at day 90
Measured: 90 days or at hospital discharge (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start26 Apr 2023
- Primary completion8 Jan 2026
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated in a 1:1 ratio to receive either an infusion of D5W + sodium bicarbonate, or D5W alone.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ary Serpa Neto, PhD, Principal investigator, ANZIC RC, Monash university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697770
- Sponsor's protocol ID
- ANZIC-RC/ASN001
- Acronym
- SODa-BIC
- Status last verified
- Mar 2026
- First submitted
- 15 Jan 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
SODa-BIC Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group; Serpa Neto A, McNamara M, White K, Cooper DJ, Fujii T, Higgins AM, Hodgson CL, Navarra L, Nichol A, Peake S, Rea-Neto A, Secombe P, Osborne F, Burrill H, See E, Young M, Zampieri FG, Plummer M, Christie C, Nunnink L, Mackay J, McGuinness S, Marmol J, Tiruvoipati R, Bailey M, Young PJ, Bellomo R, Udy A. Sodium Bicarbonate for Critically Ill Adults with Metabolic Acidosis and Shock. N Engl J Med. 2026 Jun 12. doi: 10.1056/NEJMoa2600526. Online ahead of print.
PubMed 42283370Serpa 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.
PubMed 40487345
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SODium BICarbonate for Metabolic Acidosis in the Intensive Care Unit (SODa-BIC): A Multicentre, Randomised, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05697770
- Acronym / sponsor ID
- SODa-BIC / ANZIC-RC/ASN001
- Conditions
- Metabolic Acidosis, Shock
- Keywords
- Sodium bicarbonate, Metabolic acidosis, Shock, Clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated in a 1:1 ratio to receive either an infusion of D5W + sodium bicarbonate, or D5W alone.
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Experimental | Drug: Sodium bicarbonateSodium 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). |
| 5% dextrose | Active comparator | Drug: 5% DextroseStandard 500 mL bag of D5W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonateSodium 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. | Drug | Sodium bicarbonate |
| 5% Dextrose5% 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. | Drug | 5% dextrose |
Primary outcome
MAKE30 score
Time frame: 30 days or at hospital discharge (whichever occurs first)
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.
7 secondary outcomes
30-day in-hospital mortality
Time frame: 30 days or at hospital discharge (whichever occurs first)
Receipt of renal replacement therapy in the first 30 days
Time frame: 30 days or at hospital discharge (whichever occurs first)
Persistent renal dysfunction
Time frame: 30 days or at hospital discharge (whichever occurs first)
Renal replacement therapy dependence at day 30
Time frame: 30 days or at hospital discharge (whichever occurs first)
ICU mortality
Time frame: 30 days or at hospital discharge (whichever occurs first)
Hospital mortality
Time frame: 90 days or at hospital discharge (whichever occurs first)
90-day in-hospital mortality
Time frame: 90 days or at hospital discharge (whichever occurs first)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 42283370SODa-BIC Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group; Serpa Neto A, McNamara M, White K, Cooper DJ, Fujii T, Higgins AM, Hodgson CL, Navarra L, Nichol A, Peake S, Rea-Neto A, Secombe P, Osborne F, Burrill H, See E, Young M, Zampieri FG, Plummer M, Christie C, Nunnink L, Mackay J, McGuinness S, Marmol J, Tiruvoipati R, Bailey M, Young PJ, Bellomo R, Udy A. Sodium Bicarbonate for Critically Ill Adults with Metabolic Acidosis and Shock. N Engl J Med. 2026 Jun 12. doi: 10.1056/NEJMoa2600526. Online ahead of print.
- Derived from this study: PubMed 40487345Serpa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ary Serpa Neto, PhD principal investigator
ANZIC RC, Monash university
55 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium bicarbonate and 5% Dextrose in people with Metabolic Acidosis and Shock, run by Australian and New Zealand Intensive Care Research Centre at 55 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in Australia, New Zealand, India, Brazil, Japan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAKE30 score (time frame: 30 days or at hospital discharge (whichever occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697770, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.