Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane

NCT06543940 | Recruiting

• 1 other identifier: MUPY00001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

AKI - Acute Kidney Injury

Keywords

vancomycin; CRRT; oXiris membrane

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• To determine the Cmax of vancomycin

  1 year

• 30-day mortality rate

  30 day after intervention period

• percentage of patients who, receiving AUC/MIC ratio within the range of 400 to 600 mg*h/L.

  1 years

• incidence of adverse effects of vancomycin

  1 years

• renal recovery rate at 30 days

  30 day after intervention period

Study Arms (1)

Vancomycin

EXPERIMENTAL

administration with vancomycin 7.5 to 10 mg/kg IV q 12 hours in patient received CRRT with oXiris membrane

Drug: Vancomycin

Interventions

Vancomycin DRUG

vancomycin dose is 7.5 to 10 mg/kg

Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with a history of vancomycin allergy.
• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Facullty of Pharmacy Mahidol University

Bangkok, Payathi, 10400, Thailand

RECRUITING

Related Publications (5)

• 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.

  PMID: 25753888 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.

  PMID: 32191793 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.

  PMID: 15327585 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.

  PMID: 21636256 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.

  PMID: 33033945 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

chidtawan Hirunsomboon, PharmD

CONTACT

+66-988309558; chidtawan.hir@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer faculty of pharmacy

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 9, 2024
• Study Start: September 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 31, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)