Protocol summary and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial
Bibliographic record
Abstract
Background: Metabolic acidosis is common in critically ill patients and is associated with increased risk of organ dysfunction, need for renal replacement therapy, and death. Despite its frequency and clinical relevance, the optimal treatment approach remains uncertain. Sodium bicarbonate is often used to correct acidosis, but its risk-benefit profile in this setting is unclear. Objective: To describe the study protocol and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial. Design setting and participants: Protocol for an international, multicentre, randomised, double-blind, parallel-group, superiority adaptive clinical trial. Five hundred (n = 500) adults with metabolic acidosis and receiving a continuous infusion of a vasopressor will be randomly assigned to sodium bicarbonate or placebo in a 1:1 ratio. SODa-BIC started recruiting in April 2023. It is anticipated that recruitment will be completed in 2026. Main outcome measures: The primary outcome will be major adverse kidney events within 30 days (MAKE30). Secondary and tertiary outcomes include 30- and 90-day mortality, receipt of renal replacement therapy, and vasopressor-free and ICU-free days at day 30. All analyses will be conducted on an intention-to-treat basis. Results and conclusions: SODa-BIC will evaluate whether sodium bicarbonate improves clinically meaningful outcomes in critically ill patients with metabolic acidosis. The trial has the potential to inform international practice guidelines and provide robust evidence to guide the treatment of a common and severe condition in the intensive care unit. Registration: Clinicaltrials.gov (NCT05697770).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".