Initial Evaluation of Sodium-Free Intraperitoneal 30% Icodextrin/10% Dextrose Solution to Test Short-Term Safety, Tolerability, and Preliminary Efficacy
Bibliographic record
Abstract
Background: Currently used peritoneal dialysis (PD) solutions contain salt limiting their diffusive ability to remove sodium (Na). Na removal is largely dependent on convection, and this becomes increasingly challenging with impending ultrafiltration failure, leading to accumulation of tissue based Na and contributing to increased morbidity/mortality. The aim of this study was to demonstrate the short-term safety, tolerability, and efficacy of a Na-free, PD solution (based 30% Icodextrin) to achieve high-efficiency peritoneal Na and volume removal. Methods: We studied 10 patients in a single-arm, open label, interventional trial. Stable PD patients aged > 18 years without uncontrolled diabetes mellitus or active infections were enrolled. Study participants received one 4-6-hour dwell of a Na-free PD solution (500 ml instillation volume). They were monitored for pain, hemodynamics, serum sodium and peritoneal removal of sodium and water. Results: Participants who completed the study reported mild to moderate abdominal pain (1-2/5 pain scale). BP, HR, cardiac output, and stroke volume did not change throughout procedure. Total Na removed per session was 5.69 ± 0.88 g (effluent), ultrafiltrate volume removed was 1975 ± 319 mL, total weight reduction 1.02 ± 0.24kg (p= 0.03). Serum Na remained stable throughout treatment (134.4 ± 5.7mmol/L - 133.3 ± 6.8mmol/L). Na concentration in effluent progressively increased each hour from 90.80 ± 12.36 to 125.4 ± 7.61 mmol/L (p = 0.002). Serum osmolality remained unchanged Conclusion: We have demonstrated the safety, efficacy, and tolerability of a new Na-free hypertonic PD solution, able to remove >5 g of Na and approximately 2 L of fluid in a single session, without hemodynamic challenge or short term hyponatremia.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| 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".