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SODium BICarbonate for Metabolic Acidosis in the ICU
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
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-04-26
Primary completion: 2026-07-01
Study completion finish: 2027-06-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05697770
Intervention or treatment
DRUG: Sodium bicarbonate
DRUG: 5% Dextrose
Conditions
- • Metabolic Acidosis
- • Shock
Find a site
Closest Location:
Royal Prince Alfred Hospital
Research sites nearby
Select from list below to view details:
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
Calvary Mater Newcastle
Waratah, New South Wales, Australia
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/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Sodium bicarbonate
| DRUG: Sodium bicarbonate
|
ACTIVE_COMPARATOR: 5% dextrose
| DRUG: 5% Dextrose
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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 outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| 30-day in-hospital mortality | All-cause in-hospital mortality at day 30 | 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 | 30 days or at hospital discharge (whichever occurs first) |
| Persistent renal dysfunction | Defined as an elevation of the creatinine level to ≥ 200% of baseline | 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 | 30 days or at hospital discharge (whichever occurs first) |
| ICU mortality | All-cause ICU mortality at day 30 | 30 days or at hospital discharge (whichever occurs first) |
| Hospital mortality | All-cause hospital mortality at day 90 | 90 days or at hospital discharge (whichever occurs first) |
| 90-day in-hospital mortality | All-cause mortality at day 90 | 90 days or at hospital discharge (whichever occurs first) |
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