None listed
Conditions
Brief summary
Vancomycin is commonly used in dialysis patients. Vancomycin is washed out on dialysis. We are currently using Theranova dialyser compared to previously Revaclear. We hypothesis that Theranova will have higher clearance of vancomycin when compared to Revaclear. During the study, if you are on Vancomycin, then we will alternate the dialyser (filter) between each session for a total of six sessions over 2 weeks period. Blood test will be done during the study to help us understand how antibiotics is cleared.
Interventions
In centre haemodialysis patients needing (Vancomycin: drug of the study) as deemed necessary by their dialysis doctor, will be enrolled in the study. Vancomycin will be given over 6 dialysis sessions based on trough concentration. We understand how vancomycin is cleared on Revaclear but not on Theranova, therefore, subjects' dialysis sessions will alternate between Revaclear and Theranova dialyzers. During the study, we will look at vancomycin clearance on the two diffierent dialysers.
The dur
In centre haemodialysis patients needing (Vancomycin: drug of the study) as deemed necessary by their dialysis doctor, will be enrolled in the study. Vancomycin will be given over 6 dialysis sessions based on trough concentration. We understand how vancomycin is cleared on Revaclear but not on Theranova, therefore, subjects' dialysis sessions will alternate between Revaclear and Theranova dialyzers. During the study, we will look at vancomycin clearance on the two diffierent dialysers. The duration of each dialysis session will depend on patients' dialysis prescription before the study. the minimum is 4 hours per session and maximum is 5 hours. Patients are usually prescribed 3 session per week (either Mon, Wed, Friday) or (Tues, Thurs, Sat). Before the study starts, patients will already be on Theranova. so loading dose of vancomycin will be on Theranova. The first dialysis session (day 1 of study), patient will be start with Theranova. Day 2 will be on Revaclear, day 3 will be on Theranova, day 4 will be on Revaclear, day 5 will on Theranova and day 6 will on Revaclear. then patient will be returned to Theranova permanently. The principal investigator will be responsible for reviewing subjects each session along with reading notes, reviewing nursing notes, talking to patients and signing of the patient data sheet for each treatment. This is a pilot study and numbers are small so it can be done. We would also ask one of the co-investigators to review notes to make sure nothing was missed out around data collection time. The loading dose of vancomycin is 30mg/kg on day 0 as prescribed by the dialysis doctor. The next dose will depend on vancomycin trough concentration (i.e. before starting dialysis). A maintenance dose of 10 – 15 mg/kg will be administered at each session when pre-dialysis concentration is less than or equal to 20 mg/L in infections. The dose will be delivered in the last 60-120 minutes of a dialysis session. The maximum dose delivered would be 2000mg. The Principle Investigator will review all test results and adverse events reported prior to the next dose. The dose will be adjusted based on review of pre-dialysis vancomycin concentration by the Principle investigator. Dose adjustments will be made in an approximately linear fashion in accordance with trough plasma levels. For example, an increase in dose by 50% would result in an increase in trough level by approximately 50% and vice versa
Sponsors
Hastings hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The following are the inclusion criteria: 1. Male or female over the age of 18. 2. Be an In-centre haemodialysis subject using a middle cut-off dialyser (Theranova) 3. Female subjects of child bearing age must have a negative serum pregnancy test at baseline 4. Females of child-bearing potential must be non-pregnant and not lactating at the time of the study 5. Not allergic or have had an adverse reaction to vancomycin previously 6. Provide written informed consent 7. Have the ability to understand the requirements of the study and to comply with the study protocol and dosing regimen
Exclusion criteria
Subjects will be excluded from the study if they: 1. Have clinical evidence of any active significant disease that could potentially compromise the ability of the investigator to evaluate or interpret the effects of the study treatment on safety assessment and thus increase the risk to the subject to unacceptable levels 2. Are on other concomitant antibiotics at the time of the study 3. Are pregnant or nursing 4. Have a history of allergy to vancomycin 5. Are considered by the Investigator to be an unsuitable candidate for this study 6. Are on hemodiafiltration (HDF) 7. Have sensitivity (allergic reaction) to Revaclear or Theranova membranes
Outcome results
None listed