Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy With a High Adsorption Membrane (oXiris®)
NCT ID: NCT04033029
Last Updated: 2023-10-10
Study Results
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Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2021-01-01
2023-06-30
Brief Summary
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* Patients: sepsis patients undergoing continuous renal replacement therapy (CRRT) and admitted at the Intensive care unit of Bellvitge University Hospitals. No power calculations needed.
* Antibiotic treatment: piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin as their standard of care and doses will be at the discretion of the treating physician.
* CRRT treatment: continuous venovenous hemodiafiltration (CVVHDF) will be performed by using the PrismafleX eXeed™ system with a high adsorbent membrane (oXiris®).
* Antibiotic concentrations: blood pre and post filter, urine and ultrafiltrate samples will be collected at steady state conditions. Samplig time will depend on dosage regimens of each antibiotic.
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Detailed Description
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Setting: this study will be conducted at the Intensive Care Unit at the Bellvitge University Hospital.
Study aims: the primary objective is to determine the PK/PD target attainment of piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin in septic critically ill patients treated with CVVHDF using oXiris® membrane. Secondary aims are: i) to characterize the PK of piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin in critically ill patients under CVVHDF therapy using oXiris® membrane by developing a population PK model; ii) to identify the clinical and demographic sources of PK variability observed in these patient and iii) to develop individualized dosing recommendations based on the PK/PD index associated with therapy success.
Recruitment process: patients who meet the inclusion criteria will be enrolled for at least 72 hours (maximum 96 hours).
Sample size: no power calculations are required for this study as it aims to investigate the PK of these antibiotics and does not intend to measure the effect of an intervention between two groups.
Antibiotic treatment: patients will receive piperacillin, ceftazidime, cefepime, ceftolozane/tazobactam or daptomycin as their standard of care. Doses will be at the discretion of the treating physician. At the same time, patients will be treated under continuous renal replacement techniques (CRRT) with continuous venovenous hemodiafiltration mode (CVVHDF) using PrismafleX eXeed™ system and high adsorbent polyethyleneimide membrane (oXiris®). Filtration parameters will be determined following the local protocol (dose of 25-30 ml/kg/h) CRRT initiation will be determined by the treating physician on charge, according with the current recommendations of clinical practice and prescriptions of CRRT and local management protocols. The decision to stop the treatment will be determined by:
* Adequate renal recovery status: adequate capacity to effectively maintain fluid and electrolyte homeostasis and urinary output (\>450 ml in 24 h) without the use of diuretics.
* Hemodynamic stability without renal function recovery. Therapy will be continued as intermittent hemodialysis.
Antibiotic concentrations: blood, either pre and post filtration through oXiris® membrane, urine and ultrafiltrate samples will be obtained. Samples will be collected at 1) steady state conditions and 2) after minimum 24h from the concomitant administration of CRRT and antibiotic for piperacillin, ceftazidime, cefepime, ceftolozane and 48h for daptomycin. Sampling times will depend on the dosage regimen of each antibiotic therapy. Drug concentrations will be determined using a previously developed and validated measurement procedure based on ultra-high performance liquid chromatography-tandem mass spectrometry.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients under CVVHDF with high adsorption membrane
Continuous venovenous hemodiafiltration mode (CVVHDF) using PrismafleX eXeed™ system and high adsorbent polyethyleneimide membrane (oXiris®). Filtration parameters will be determined following the local protocol (dose of 25-30 ml/kg/h).
Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®)
CRRT initiation will be determined by the treating physician on charge, according with the current recommendations of clinical practice and prescriptions of CRRT and local management protocols. The CVVHDF mode will be performed by using PrismafleX eXeed™ system and high adsorbent polyethyleneimide membrane (oXiris®). Filtration parameters will be determined following the local protocol (dose of 25-30 ml/kg/h).
Antibiotics
Antibiotic concentration-time data will be collected and analyzed.
Interventions
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Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®)
CRRT initiation will be determined by the treating physician on charge, according with the current recommendations of clinical practice and prescriptions of CRRT and local management protocols. The CVVHDF mode will be performed by using PrismafleX eXeed™ system and high adsorbent polyethyleneimide membrane (oXiris®). Filtration parameters will be determined following the local protocol (dose of 25-30 ml/kg/h).
Antibiotics
Antibiotic concentration-time data will be collected and analyzed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>18 years
* Treatment with piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin prescribed at the discretion of the treating intensive care physician.
* Written informed consent will be required before the inclusion of a patient whenever possible and will be requested from the nearest relatives in the other cases.
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Helena Colom Codina
Principal Investigator
Principal Investigators
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Helena Colom Codina, Phd
Role: PRINCIPAL_INVESTIGATOR
Universitat Autònoma de Barcelona
Locations
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Helena Colom Codina
Barcelona, , Spain
Countries
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References
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Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.
Brun-Buisson C. The epidemiology of the systemic inflammatory response. Intensive Care Med. 2000;26 Suppl 1(Suppl 1):S64-74. doi: 10.1007/s001340051121.
Kollef MH, Sherman G, Ward S, Fraser VJ. Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients. Chest. 1999 Feb;115(2):462-74. doi: 10.1378/chest.115.2.462.
Zaragoza R, Artero A, Camarena JJ, Sancho S, Gonzalez R, Nogueira JM. The influence of inadequate empirical antimicrobial treatment on patients with bloodstream infections in an intensive care unit. Clin Microbiol Infect. 2003 May;9(5):412-8. doi: 10.1046/j.1469-0691.2003.00656.x.
Pinder M, Bellomo R, Lipman J. Pharmacological principles of antibiotic prescription in the critically ill. Anaesth Intensive Care. 2002 Apr;30(2):134-44. doi: 10.1177/0310057X0203000203.
Ibrahim EH, Sherman G, Ward S, Fraser VJ, Kollef MH. The influence of inadequate antimicrobial treatment of bloodstream infections on patient outcomes in the ICU setting. Chest. 2000 Jul;118(1):146-55. doi: 10.1378/chest.118.1.146.
Craig WA. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis. 1998 Jan;26(1):1-10; quiz 11-2. doi: 10.1086/516284.
Roberts JA, Roberts MS, Robertson TA, Dalley AJ, Lipman J. Piperacillin penetration into tissue of critically ill patients with sepsis--bolus versus continuous administration? Crit Care Med. 2009 Mar;37(3):926-33. doi: 10.1097/CCM.0b013e3181968e44.
Heinemeyer G, Link J, Weber W, Meschede V, Roots I. Clearance of ceftriaxone in critical care patients with acute renal failure. Intensive Care Med. 1990;16(7):448-53. doi: 10.1007/BF01711224.
Trotman RL, Williamson JC, Shoemaker DM, Salzer WL. Antibiotic dosing in critically ill adult patients receiving continuous renal replacement therapy. Clin Infect Dis. 2005 Oct 15;41(8):1159-66. doi: 10.1086/444500. Epub 2005 Sep 12.
Carcelero San Martin E, Soy Muner D. [Dosage of antipseudomonal antibiotics in patients with acute kidney injury subjected to continuous renal replacement therapies]. Med Intensiva. 2013 Apr;37(3):185-200. doi: 10.1016/j.medin.2012.02.012. Epub 2012 Apr 3. Spanish.
Matzke GR, Frye RF, Joy MS, Palevsky PM. Determinants of ceftazidime clearance by continuous venovenous hemofiltration and continuous venovenous hemodialysis. Antimicrob Agents Chemother. 2000 Jun;44(6):1639-44. doi: 10.1128/AAC.44.6.1639-1644.2000.
Bauer SR, Salem C, Connor MJ Jr, Groszek J, Taylor ME, Wei P, Tolwani AJ, Fissell WH. Pharmacokinetics and pharmacodynamics of piperacillin-tazobactam in 42 patients treated with concomitant CRRT. Clin J Am Soc Nephrol. 2012 Mar;7(3):452-7. doi: 10.2215/CJN.10741011. Epub 2012 Jan 26.
Valtonen M, Tiula E, Backman JT, Neuvonen PJ. Elimination of meropenem during continuous veno-venous haemofiltration and haemodiafiltration in patients with acute renal failure. J Antimicrob Chemother. 2000 May;45(5):701-4. doi: 10.1093/jac/45.5.701.
Roberts DM, Roberts JA, Roberts MS, Liu X, Nair P, Cole L, Lipman J, Bellomo R; RENAL Replacement Therapy Study Investigators. Variability of antibiotic concentrations in critically ill patients receiving continuous renal replacement therapy: a multicentre pharmacokinetic study. Crit Care Med. 2012 May;40(5):1523-8. doi: 10.1097/CCM.0b013e318241e553.
Seyler L, Cotton F, Taccone FS, De Backer D, Macours P, Vincent JL, Jacobs F. Recommended beta-lactam regimens are inadequate in septic patients treated with continuous renal replacement therapy. Crit Care. 2011;15(3):R137. doi: 10.1186/cc10257. Epub 2011 Jun 6.
Rigo-Bonnin R, Ribera A, Arbiol-Roca A, Cobo-Sacristan S, Padulles A, Murillo O, Shaw E, Granada R, Perez-Fernandez XL, Tubau F, Alia P. Development and validation of a measurement procedure based on ultra-high performance liquid chromatography-tandem mass spectrometry for simultaneous measurement of beta-lactam antibiotic concentration in human plasma. Clin Chim Acta. 2017 May;468:215-224. doi: 10.1016/j.cca.2017.03.009. Epub 2017 Mar 10.
Other Identifiers
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HCC-PIP-2018-01
Identifier Type: -
Identifier Source: org_study_id
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