Development of a Novel Intraperitoneal Icodextrin/Dextrose Solution for Enhanced Sodium Removal
Bibliographic record
Abstract
Rationale & Objective Peritoneal dialysis (PD) solutions provide both clearance of uremic toxins and sodium and water. An intraperitoneal (IP) solution of icodextrin and glucose designed without the requirement for uremic toxin clearance could provide substantially greater sodium and water removal than PD solutions. Study Design We examined varying concentrations of icodextrin and dextrose IP solutions in rats. We evaluated a 30% icodextrin and 10% dextrose IP solution in animals and humans. Participants Small and large animal models, and humans (N=10) with kidney failure. Exposure 30% icodextrin and 10% dextrose IP solution. Outcomes We evaluated ultrafiltration (UF), sodium removal, and peritoneal health in animals. We evaluated safety, tolerability, and efficacy in humans. Results In rats, increasing concentrations of icodextrin and dextrose IP solutions, up to 30% icodextrin and 10% dextrose, produced progressively greater UF ( P <0.001). In sheep treated with 30% icodextrin and 10% dextrose, the mean UF was ∼3.5-fold greater (1.77±0.22L vs 0.47±0.34L; P =0.005) and the mean sodium removal was ∼4-fold greater (7.07±0.72g vs 1.78±1.27g; P =0.003) compared with commercially available 7.5% icodextrin PD solution. Long-term exposure of mice (30 days) and sheep (30-45 days) to a 30% icodextrin and 10% dextrose IP solution resulted in no significant structural tissue changes compared with the control 4.25% commercially available PD solution. In humans, a 24-hour dwell of a 30% icodextrin and 10% dextrose IP solution resulted in median net UF of 2,498mL (IQR, 2,249-2,768), and median sodium removal of 387mmol (IQR, 372-434mmol). No serious adverse events occurred. Limitations The long-term safety with chronic therapy and the efficacy in patients without kidney failure were not established and require future studies. Conclusions A 30% icodextrin and 10% dextrose IP solution provides more efficient UF and sodium removal than traditional PD solutions. The promising inhuman safety and efficacy results warrant future investigation as a sodium removal therapy in patients with edematous disorders such as heart failure. Clinical Trial Registration NCT05780086. Summary We aimed to design a novel intraperitoneal solution designed for optimal sodium and water removal. A sodium-free 30% icodextrin and 10% dextrose intraperitoneal solution was evaluated in animal models and humans to determine the safety and efficacy. A 30% icodextrin and 10% dextrose solution provides more efficient sodium and water removal than traditional peritoneal dialysis solutions. The promising inhuman safety and efficacy results warrant future investigation as a sodium removal therapy in patients with edematous disorders such as heart failure. Plain-Language Summary We aimed to design a novel intraperitoneal solution designed for optimal sodium and water removal. A sodium-free 30% icodextrin and 10% dextrose intraperitoneal solution was evaluated in animal models and humans to determine the safety and efficacy. A 30% icodextrin and 10% dextrose solution provides more efficient sodium and water removal than traditional peritoneal dialysis solutions. The promising inhuman safety and efficacy results warrant future investigation as a sodium removal therapy in patients with edematous disorders such as heart failure.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 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 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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 source (direct Gemma or distilled Codex), 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".