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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin | Experimental | administration with vancomycin 7.5 to 10 mg/kg IV q 12 hours in patient received CRRT with oXiris membrane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | vancomycin dose is 7.5 to 10 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after intervention vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the Cmax of vancomycin | calculated Cmax of vancomycin in these patient by phoenix winnonlin software. | 1 year |
| 30-day mortality rate | monitor mortality rate at 30 days after received maintenance dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chidtawan Hirunsomboon, PharmD | Contact | +66-988309558 | chidtawan.hir@mahidol.ac.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facullty of Pharmacy Mahidol University | Recruiting | Bangkok | Payathi | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25753888 | Background | 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. | |
| 32191793 | Background | Rybak 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. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| 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. | 1 years |
| incidence of adverse effects of vancomycin | record the incidence of adverse effects during the intervention period. | 1 years |
| renal recovery rate at 30 days | monitor renal replacement therapy status at 30 days after received maintenance dose | 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. | 1 years |
| To determine the volume of distribution (Vd) of vancomycin | calculated Vd of vancomycin in these patient by phoenix winnonlin software. | 1 years |
| To determine the half life of vancomycin | calculated half life of vancomycin in these patient by phoenix winnonlin software. | 1 years |
| 15327585 | Background | DelDot 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. |
| 21636256 | Background | Chaijamorn 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. |
| 33033945 | Background | Onichimowski 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |