Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection
- Conditions
- Peritoneal DialysisEnd Stage Renal Disease
- Interventions
- Other: Normal salineOther: Chlorhexidine gluconate-soaked clothsOther: mupirocin ointment
- Registration Number
- NCT02547103
- Lead Sponsor
- Chiang Mai University
- Brief Summary
This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline) with aseptic technique in prevention of PD-related infection. It is a multicenter, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be followed up 24 months or completion of PD. The primary outcome is PD-related infection (PD-related peritonitis of exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related quality of life, mental health, medication adherence, safety, adverse events related to treatments such as skin irritation, rash, etc. Costs include providers and patients expenses. The utility is assessed using the EuroQol (EQ), five-dimensional (5D), five-level (5L) version. The results of this study are anticipated nephrologists and health care professional involving to PD in decision-making for a plan to prevent PD-related infection. In addition, the results will lead to clinical guideline development a prevention of PD-related infection.
- Detailed Description
Peritoneal dialysis (PD) is one of renal replacement therapy used for end-stage renal disease. Since 2011, there has been increasing numbers of patients under "PD First" policy of the Thai government. The most common PD related complication is PD-related infection categorized PD-related peritonitis, and exit site and tunnel infection. Although possible to treat PD-related infection, the incidence of technical failure and death due to peritonitis are still high in Thailand. PD-related infections mainly caused by Staphylococcus aureus. To prevent PD-related infection, cleaning with aseptic solvents using aseptic technique and prevent infection by prescribing prophylactic antibiotics are recommended. The International Society for Peritoneal Dialysis (ISPD) has recommended position statement of the regular use of mupirocin ointment around the catheter exits point and apply in nasal cavity. However, there is rising concern of long term use of mupirocin for mupirocin resistance of S. aureus. CHG is antiseptic use in clinical practice. It can coat at least 12 hours on skin and has anti-bacterial covered in both grams negative and positive. Several meta-analysis studies showed effectiveness of CHG in the prevention of hospitals infection i.e. reduces catheter-related sepsis, postoperative infection, and microbial resistance. According to PD-related infection, CHG has very little evidence of its effectiveness. This pilot study aims to evaluate effectiveness, safety, and cost-utility of CHG-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline and povidone-iodine) with aseptic technique in prevention of PD-related infections. It is a multicenter, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths. They will be followed up 24 months or completetion of PD. The primary outcome is PD-related infection (PD-related peritonitis or exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related quality of life, mental health, medication adherence, safety, adverse events related to treatments such as skin irritation, rash, etc. For cost-utility analysis, costs include providers and patients expenses. The Utility is assessed using EQ-5D-5L.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 354
- Patients with end-stage renal disease who were undergoing peritoneal dialysis; either continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD)
- History of psychological illness or condition that interferes with the ability to understand or comply with the requirements of the study
- Recent (within 1 month) exit-site or tunnel infection, or peritonitis
- Known hypersensitivity to, or intolerance of, chlorhexidine gluconate, or mupirocin
- Current or recent (within 1 month) treatment with antibiotics administered by any route
- Nasal carriage of mupirocin-resistant Staphylococcus aureus or chlorhexidine-resistant S. aureus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal saline (usual care) Normal saline Normal saline, clean topical area around catheter exit site Chlorhexidine gluconate Chlorhexidine gluconate-soaked cloths Chlorhexidine gluconate-soaked cloths, clean topical area around catheter exit site with CHG 2% soaked cloths Mupirocin ointment mupirocin ointment Mupirocin ointment 2%, clean topical area around catheter exit site with Mupirocin ointment
- Primary Outcome Measures
Name Time Method Incidence of PD-related infections 24 months Peritonitis or exit-site and tunnel infection
- Secondary Outcome Measures
Name Time Method Incidence of PD technical failure (change of modal of dialysis) 24 months change of modal of dialysis
Incidence of hospitalization due to PD-related infection 24 months Changes in health-related quality of life 24 months Using the Kidney Disease Quality of Life-36 (KDQOL-36), EuroQoL-5 dimension-5 level (EQ-5D-5L)
Rate of Staphylococcus aureus colonization 24 months Incidence of nasal or exit-site S. aureus colonization
Total healthcare costs 24 months Direct medical costs, direct non-medical costs, and indirect costs
Incidence of death due to PD-related infection 24 months Death due to peritonitis or exit-site and tunnel infection
Incidence of infection-related catheter removal 24 months Peritonitis or exit-site and tunnel infection-related catheter removal
Changes in medication adherence 24 months Using (i) directly observed to record the use of investigational medicinal products via return plastic sachets and ointment tubes; (ii) global rating on medication adherence by visual analog scale; and (iii) Medication-taking behavior measure for Thai patients (MTB-Thai questionnaire
Incidence of skin reactions 24 months Number of participants with depression 24 months Using the Beck Depression Inventory II (BDI-II)
Trial Locations
- Locations (1)
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Chiang Mai, Thailand