Optimising intraperitoneal gentamicin dosing in peritoneal dialysis patients with peritonitis (GIPD) study.
BACKGROUND
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
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.


CONCLUSIONS
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.


BACKGROUND
ACTRN12609000446268.
Ranganathan
Dwarakanathan
D
Renal Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, 4029 Australia. Dwarakanathan_Ranganathan@health.qld.gov.au
Varghese
Julie M
JM
Fassett
Robert G
RG
Lipman
Jeffrey
J
D'Intini
Vincent
V
Healy
Helen
H
Roberts
Jason A
JA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005839:Gentamicins / Q000008:administration & dosage*; D006801:Humans; D007263:Infusions, Parenteral; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis / Q000009:adverse effects*; D010538:Peritonitis / Q000188:drug therapy* / Q000209:etiology*; D016896:Treatment Outcome; D055815:Young Adult
D000900:Anti-Bacterial Agents; D005839:Gentamicins