Development of a Novel Intraperitoneal Icodextrin/Dextrose Solution for Enhanced Sodium Removal
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Notice bibliographique
Résumé
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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Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
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Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
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