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Clinical Trials in Japan / NCT05697770
Active, not recruiting Phase 3

SODium BICarbonate for Metabolic Acidosis in the ICU

NCT05697770 · tracked via the Priya Life Science Japan tracker
Sponsor
Australian and New Zealand Intensive Care Research Centre
Phase
Phase 3
Started
2023-04-26
Last updated
2026-03-27

Condition(s) studied

Metabolic AcidosisShock

Investigational drug(s) / intervention(s)

Sodium bicarbonate →5% Dextrose

Sodium bicarbonate: 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% Dextrose: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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. 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); and 4. Metabolic acidosis, defined as: 1. pH \< 7.30; and 2. BE ≤ -4 mEq/L; and 3. 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; or 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); or 3. DKA; or 4. Estimated glomerular filtration rate (eGFR) \< 30 mL/min due to chronic kidney disease; or 5. Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed); or 6. Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team); or 7. Severe dysnatraemia (serum Na ≥ 155 mEq/L or \< 120 mEq/L); or 8. Hypokalaemia (serum K \< 2.5 mEq/L); or 9. Pulmonary oedema with PaO2 / FiO2 \< 100; or 10. Hypocalcaemia (iCa \< 0.8mmol/L); or 11. Patients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication); or 12. Pregnancy or breastfeeding; or 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; or 14. Patients with a life expectancy \< 30 days due to a chronic or underlying medical condition; or 15. Considered to be at high risk of cerebral oedema by the treating clinician (e.g. traumatic brain injury or acute brain disease); or 16. Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; or 17. Previous enrolment in this study.

Primary outcome measure(s)

  • MAKE30 score — 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.

Trial sites (55)

FacilityCityRegionStatus
Canberra Hospital Garran Australian Capital Territory
Royal Prince Alfred Hospital Camperdown New South Wales
Sutherland Hospital Caringbah New South Wales
St Vincent's Hospital Sydney Darlinghurst New South Wales
Gosford Hospital Gosford New South Wales
Nepean Hospital Kingswood New South Wales
Orange Health Service Orange New South Wales
Royal North Shore Hospital Saint Leonards New South Wales
Sydney Adventist Hospital Wahroonga New South Wales
Calvary Mater Newcastle Waratah New South Wales
Royal Darwin Hospital Tiwi Northern Territory
Sunshine Coast University Hospital Birtinya Queensland
Cairns Hospital Cairns Queensland
Queen Elizabeth II Jubilee Hospital Coopers Plains Queensland
Townsville University Hospital Douglas Queensland
Royal Brisbane and Women's Hospital Herston Queensland
Ipswich Hospital Ipswich Queensland
Mater Hospital South Brisbane Queensland
Gold Coast University Hospital Southport Queensland
Princess Alexandra Hopsital Woolloongabba Queensland
Royal Adelaide Hospital Adelaide South Australia
Flinders Medical Centre Bedford Park South Australia
Lyell McEwin Hospital Elizabeth Vale South Australia
The Queen Elizabeth Hospital Woodville South Australia
Grapmians Health Ballarat Victoria
Bendigo Hospital Bendigo Victoria
Casey Hospital Berwick Victoria
The Victorian Heart Hospital Clayton Victoria
Monash Medical Centre Clayton Victoria
Dandenong Hospital Dandenong Victoria
St. Vincent's Hospital Melbourne Fitzroy Victoria
Footscray Hospital Footscray Victoria
Frankston Hospital Frankston Victoria
University Hospital Geelong Geelong Victoria
The Austin Hospital Heidelberg Victoria
Peninsula Private Hospital Langwarrin Victoria
The Alfred Hospital Melbourne Victoria
Epworth Richmond Victoria
Sunshine Hospital St Albans Victoria
Bunbury Regional Hospital Bunbury Western Australia

+ 15 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05697770 on ClinicalTrials.gov ↗ ← All trials in Japan