Renal Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, 4029 Australia.
BMC Nephrol. 2009 Dec 16;10:42. doi: 10.1186/1471-2369-10-42.
Antibiotics are preferentially delivered via the peritoneal route to treat peritonitis, a major complication of peritoneal dialysis (PD), so that maximal concentrations are delivered at the site of infection. However, drugs administered intraperitoneally can be absorbed into the systemic circulation. Drugs excreted by the kidneys accumulate in PD patients, increasing the risk of toxicity. The aim of this study is to examine a model of gentamicin pharmacokinetics and to develop an intraperitoneal drug dosing regime that maximises bacterial killing and minimises toxicity.
METHODS/DESIGN: This is an observational pharmacokinetic study of consecutive PD patients presenting to the Royal Brisbane and Women's Hospital with PD peritonitis and who meet the inclusion criteria. Participants will be allocated to either group 1, if anuric as defined by urine output less than 100 ml/day, or group 2: if non-anuric, as defined by urine output more than 100 ml/day. Recruitment will be limited to 15 participants in each group. Gentamicin dosing will be based on the present Royal Brisbane & Women's Hospital guidelines, which reflect the current International Society for Peritoneal Dialysis Peritonitis Treatment Recommendations. The primary endpoint is to describe the pharmacokinetics of gentamicin administered intraperitoneally in PD patients with peritonitis based on serial blood and dialysate drug levels.
The study will develop improved dosing recommendations for intraperitoneally administered gentamicin in PD patients with peritonitis. This will guide clinicians and pharmacists in selecting the most appropriate dosing regime of intraperitoneal gentamicin to treat peritonitis.
ACTRN12609000446268.
抗生素通过腹腔途径给药，以治疗腹膜炎，这是腹膜透析（PD）的主要并发症，以便在感染部位给予最大浓度。然而，腹腔内给予的药物可以被吸收到体循环中。肾脏排泄的药物在 PD 患者中积累，增加了毒性的风险。本研究的目的是研究庆大霉素药代动力学模型，并制定一种腹腔内药物给药方案，最大限度地提高杀菌效果，最大限度地降低毒性。
方法/设计：这是一项对连续出现 PD 相关腹膜炎的 PD 患者进行的观察性药代动力学研究，这些患者符合纳入标准，并将其分配到以下两组：1 组，如果定义为尿量<100ml/天，则为无尿；2 组：如果定义为尿量>100ml/天，则为非无尿。每组将限制招募 15 名参与者。庆大霉素的剂量将基于目前的皇家布里斯班妇女医院指南，该指南反映了目前国际腹膜透析协会腹膜炎治疗建议。主要终点是根据腹膜炎 PD 患者的连续血药和透析液药物水平描述腹腔内给予庆大霉素的药代动力学。
该研究将为 PD 相关腹膜炎患者腹腔内给予庆大霉素制定更好的剂量建议。这将指导临床医生和药剂师选择最合适的腹腔内庆大霉素给药方案来治疗腹膜炎。
ACTRN12609000446268。
