AKI - Acute Kidney InjuryNCT06543940
Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane
A study testing Vancomycin in people with AKI - Acute Kidney Injury, run by Mahidol University at 1 site in Thailand.
Trial summary
This study is a general pharmacokinetic investigation of vancomycin in patients receiving continuous veno-venous hemodiafiltration (CRRT) with the oXiris membrane. This membrane offers the added benefit of absorbing inflammatory cytokines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI - Acute Kidney Injury
- What is being tested?
- Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged more than 18 years.
- Admitted to the intensive care unit of Ramathibodi Hospital.
- Under continuous renal replacement therapy (CRRT) with CVVHDF using oXiris filter.
- Received vancomycin at least once after starting CRRT with CVVHDF using oXiris filter.
- who have signed the informed consent document.
Who cannot join
- Patients with a history of vancomycin allergy.
- Patients expected to die within 24 hours after inclusion in study.
- Patients with circuit clotting occurring more than 2 hours during the blood draw period.
- Patients treated with extracorporeal membrane oxygenation (ECMO).
- Patients with a history of kidney transplantation.
- Pregnant or breastfeeding women.
- Patients who have decided to receive palliative care.
- Patients on hemodialysis or peritoneal dialysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Facullty of Pharmacy Mahidol University
Bangkok, Payathi, 10400
Chidtawan Hirunsomboon, (+66)98-8309558, chidtawan.hir@mahidol.ac.th
About this study
Official title: Pharmacokinetics of Vancomycin in Patients Receiving Continuous Veno-Venous Hemodiafiltration (CVVHDF) with the Absorptive OXiris Membrane
This study is a general pharmacokinetic investigation of vancomycin in patients receiving continuous veno-venous hemodiafiltration (CRRT) with the oXiris membrane. This membrane offers the added benefit of absorbing inflammatory cytokines. In vitro studies show that vancomycin is reduced by around 20 percent in patients using the AN69ST membrane, which is part of the oXiris membrane's structure. However, there is currently a lack of in vivo studies demonstrating the impact of the oXiris membrane on vancomycin levels. Therefore, the hypothesis of this study is that vancomycin is also reduced by absorption in the oXiris membrane. This study measures the levels of vancomycin in these patients to determine the pharmacokinetic parameters.
Read the detailed description
This study monitors the levels of the maintenance dose of vancomycin in patients receiving continuous renal replacement therapy (CRRT) with the CVVHDF mode using the oXiris membrane. Blood samples were drawn from the A-line at the following time points: 0 (predose), 2, 3, 4, 5, 6, 8, and 12 hours after drug administration. The area under the curve (AUC) of the drug was calculated using the Phoenix WinNonlin program. Additionally, we reported the pharmacokinetic profile of this drug in patients with acute kidney injury (AKI) undergoing CRRT with the oXiris membrane.
- Conditions
- AKI - Acute Kidney Injury
- Being tested
- Vancomycin
- Keywords
- vancomycin, CRRT, oXiris membrane
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
vancomycin dose is 7.5 to 10 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Experimental | administration with vancomycin 7.5 to 10 mg/kg IV q 12 hours in patient received CRRT with oXiris membrane Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of vancomycin
calculated AUC of vancomycin by 8 points of drug level. (at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after administration)
Measured: at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after intervention vancomycin
Secondary outcomes (8)
To determine the Cmax of vancomycin
calculated Cmax of vancomycin in these patient by phoenix winnonlin software.
Measured: 1 year
30-day mortality rate
monitor mortality rate at 30 days after received maintenance dose
Measured: 30 day after intervention period
percentage of patients who, receiving AUC/MIC ratio within the range of 400 to 600 mg*h/L.
calculate percent sample who AUC with in target by number sample in target divide to total population.
Measured: 1 years
incidence of adverse effects of vancomycin
record the incidence of adverse effects during the intervention period.
Measured: 1 years
renal recovery rate at 30 days
monitor renal replacement therapy status at 30 days after received maintenance dose
Measured: 30 day after intervention period
To determine the elimination rate constant (Ke) of vancomycin
calculated Ke of vancomycin in these patient by phoenix winnonlin software.
Measured: 1 years
To determine the volume of distribution (Vd) of vancomycin
calculated Vd of vancomycin in these patient by phoenix winnonlin software.
Measured: 1 years
To determine the half life of vancomycin
calculated half life of vancomycin in these patient by phoenix winnonlin software.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chidtawan Hirunsomboon, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543940
- Sponsor's protocol ID
- MUPY00001
- Status last verified
- Jan 2025
- First submitted
- 26 Jul 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruniera FR, Ferreira FM, Saviolli LR, Bacci MR, Feder D, da Luz Goncalves Pedreira M, Sorgini Peterlini MA, Azzalis LA, Campos Junqueira VB, Fonseca FL. The use of vancomycin with its therapeutic and adverse effects: a review. Eur Rev Med Pharmacol Sci. 2015 Feb;19(4):694-700.
PubMed 25753888Rybak MJ, Le J, Lodise TP, Levine DP, Bradley JS, Liu C, Mueller BA, Pai MP, Wong-Beringer A, Rotschafer JC, Rodvold KA, Maples HD, Lomaestro BM. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: A revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020 May 19;77(11):835-864. doi: 10.1093/ajhp/zxaa036. No abstract available.
PubMed 32191793DelDot ME, Lipman J, Tett SE. Vancomycin pharmacokinetics in critically ill patients receiving continuous venovenous haemodiafiltration. Br J Clin Pharmacol. 2004 Sep;58(3):259-68. doi: 10.1111/j.1365-2125.2004.02143.x.
PubMed 15327585Chaijamorn W, Jitsurong A, Wiwattanawongsa K, Wanakamanee U, Dandecha P. Vancomycin clearance during continuous venovenous haemofiltration in critically ill patients. Int J Antimicrob Agents. 2011 Aug;38(2):152-6. doi: 10.1016/j.ijantimicag.2011.04.010. Epub 2011 Jun 1.
PubMed 21636256Onichimowski D, Nosek K, Ziolkowski H, Jaroszewski J, Pawlos A, Czuczwar M. Adsorption of vancomycin, gentamycin, ciprofloxacin and tygecycline on the filters in continuous renal replacement therapy circuits: in full blood in vitro study. J Artif Organs. 2021 Mar;24(1):65-73. doi: 10.1007/s10047-020-01214-8. Epub 2020 Oct 8.
PubMed 33033945
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Vancomycin in Patients Receiving Continuous Veno-Venous Hemodiafiltration (CVVHDF) with the Absorptive OXiris Membrane
- ClinicalTrials.gov ID
- NCT06543940
- Acronym / sponsor ID
- MUPY00001
- Conditions
- AKI - Acute Kidney Injury
- Keywords
- vancomycin, CRRT, oXiris membrane
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a general pharmacokinetic investigation of vancomycin in patients receiving continuous veno-venous hemodiafiltration (CRRT) with the oXiris membrane. This membrane offers the added benefit of absorbing inflammatory cytokines. In vitro studies show that vancomycin is reduced by around 20 percent in patients using the AN69ST membrane, which is part of the oXiris membrane's structure. However, there is currently a lack of in vivo studies demonstrating the impact of the oXiris membrane on vancomycin levels. Therefore, the hypothesis of this study is that vancomycin is also reduced by absorption in the oXiris membrane. This study measures the levels of vancomycin in these patients to determine the pharmacokinetic parameters.
Detailed description
This study monitors the levels of the maintenance dose of vancomycin in patients receiving continuous renal replacement therapy (CRRT) with the CVVHDF mode using the oXiris membrane. Blood samples were drawn from the A-line at the following time points: 0 (predose), 2, 3, 4, 5, 6, 8, and 12 hours after drug administration. The area under the curve (AUC) of the drug was calculated using the Phoenix WinNonlin program. Additionally, we reported the pharmacokinetic profile of this drug in patients with acute kidney injury (AKI) undergoing CRRT with the oXiris membrane.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Experimental | Drug: Vancomycinadministration with vancomycin 7.5 to 10 mg/kg IV q 12 hours in patient received CRRT with oXiris membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged more than 18 years.
- Admitted to the intensive care unit of Ramathibodi Hospital.
- Under continuous renal replacement therapy (CRRT) with CVVHDF using oXiris filter.
- Received vancomycin at least once after starting CRRT with CVVHDF using oXiris filter.
- who have signed the informed consent document.
Key exclusion criteria (8 listed)
- Patients with a history of vancomycin allergy.
- Patients expected to die within 24 hours after inclusion in study.
- Patients with circuit clotting occurring more than 2 hours during the blood draw period.
- Patients treated with extracorporeal membrane oxygenation (ECMO).
- Patients with a history of kidney transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycinvancomycin dose is 7.5 to 10 mg/kg | Drug | Vancomycin |
Primary outcome
AUC of vancomycin
Time frame: at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after intervention vancomycin
calculated AUC of vancomycin by 8 points of drug level. (at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after administration)
8 secondary outcomes
To determine the Cmax of vancomycin
Time frame: 1 year
30-day mortality rate
Time frame: 30 day after intervention period
percentage of patients who, receiving AUC/MIC ratio within the range of 400 to 600 mg*h/L.
Time frame: 1 years
incidence of adverse effects of vancomycin
Time frame: 1 years
renal recovery rate at 30 days
Time frame: 30 day after intervention period
To determine the elimination rate constant (Ke) of vancomycin
Time frame: 1 years
To determine the volume of distribution (Vd) of vancomycin
Time frame: 1 years
To determine the half life of vancomycin
Time frame: 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Background: PubMed 25753888Bruniera FR, Ferreira FM, Saviolli LR, Bacci MR, Feder D, da Luz Goncalves Pedreira M, Sorgini Peterlini MA, Azzalis LA, Campos Junqueira VB, Fonseca FL. The use of vancomycin with its therapeutic and adverse effects: a review. Eur Rev Med Pharmacol Sci. 2015 Feb;19(4):694-700.
- Background: PubMed 32191793Rybak MJ, Le J, Lodise TP, Levine DP, Bradley JS, Liu C, Mueller BA, Pai MP, Wong-Beringer A, Rotschafer JC, Rodvold KA, Maples HD, Lomaestro BM. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: A revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020 May 19;77(11):835-864. doi: 10.1093/ajhp/zxaa036. No abstract available.
- Background: PubMed 15327585DelDot ME, Lipman J, Tett SE. Vancomycin pharmacokinetics in critically ill patients receiving continuous venovenous haemodiafiltration. Br J Clin Pharmacol. 2004 Sep;58(3):259-68. doi: 10.1111/j.1365-2125.2004.02143.x.
- Background: PubMed 21636256Chaijamorn W, Jitsurong A, Wiwattanawongsa K, Wanakamanee U, Dandecha P. Vancomycin clearance during continuous venovenous haemofiltration in critically ill patients. Int J Antimicrob Agents. 2011 Aug;38(2):152-6. doi: 10.1016/j.ijantimicag.2011.04.010. Epub 2011 Jun 1.
- Background: PubMed 33033945Onichimowski D, Nosek K, Ziolkowski H, Jaroszewski J, Pawlos A, Czuczwar M. Adsorption of vancomycin, gentamycin, ciprofloxacin and tygecycline on the filters in continuous renal replacement therapy circuits: in full blood in vitro study. J Artif Organs. 2021 Mar;24(1):65-73. doi: 10.1007/s10047-020-01214-8. Epub 2020 Oct 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vancomycin in people with AKI - Acute Kidney Injury, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact chidtawan Hirunsomboon, PharmD (+66-988309558, chidtawan.hir@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of vancomycin (time frame: at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after intervention vancomycin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06543940, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.