Effect of therapeutic drug monitoring-based dose optimization of piperacillin/tazobactam on sepsis-related organ dysfunction in patients with sepsis: a randomized controlled trial
Purpose Insufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided antibiotic therapy improves outcomes. Methods Randomized, multicenter, controlled trial from January 2017 to December 2019. Adult patients ( n = 254...
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| Published in: | Intensive care medicine Vol. 48; no. 3; pp. 311 - 321 |
|---|---|
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Berlin/Heidelberg
Springer Berlin Heidelberg
01.03.2022
Springer Springer Nature B.V |
| Subjects: | |
| ISSN: | 0342-4642, 1432-1238, 1432-1238 |
| Online Access: | Get full text |
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| Abstract | Purpose
Insufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided antibiotic therapy improves outcomes.
Methods
Randomized, multicenter, controlled trial from January 2017 to December 2019. Adult patients (
n
= 254) with sepsis or septic shock were randomly assigned 1:1 to receive continuous infusion of piperacillin/tazobactam with dosing guided by daily TDM of piperacillin or continuous infusion with a fixed dose (13.5 g/24 h if eGFR ≥ 20 mL/min). Target plasma concentration was four times the minimal inhibitory concentration (range ± 20%) of the underlying pathogen, respectively, of
Pseudomonas aeruginosa
in empiric situation. Primary outcome was the mean of daily total Sequential Organ Failure Assessment (SOFA) score up to day 10.
Results
Among 249 evaluable patients (66.3 ± 13.7 years; female, 30.9%), there was no significant difference in mean SOFA score between patients with TDM (7.9 points; 95% CI 7.1–8.7) and without TDM (8.2 points; 95% CI 7.5–9.0) (
p
= 0.39). Patients with TDM-guided therapy showed a lower 28-day mortality (21.6% vs. 25.8%, RR 0.8, 95% CI 0.5–1.3,
p
= 0.44) and a higher rate of clinical (OR 1.9; 95% CI 0.5–6.2,
p
= 0.30) and microbiological cure (OR 2.4; 95% CI 0.7–7.4,
p
= 0.12), but these differences did not reach statistical significance. Attainment of target concentration was more common in patients with TDM (37.3% vs. 14.6%, OR 4.5, CI 95%, 2.9–6.9,
p
< 0.001).
Conclusion
TDM-guided therapy showed no beneficial effect in patients with sepsis and continuous infusion of piperacillin/tazobactam with regard to the mean SOFA score. Larger studies with strategies to ensure optimization of antimicrobial exposure are needed to definitively answer the question. |
|---|---|
| AbstractList | Insufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided antibiotic therapy improves outcomes.PURPOSEInsufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided antibiotic therapy improves outcomes.Randomized, multicenter, controlled trial from January 2017 to December 2019. Adult patients (n = 254) with sepsis or septic shock were randomly assigned 1:1 to receive continuous infusion of piperacillin/tazobactam with dosing guided by daily TDM of piperacillin or continuous infusion with a fixed dose (13.5 g/24 h if eGFR ≥ 20 mL/min). Target plasma concentration was four times the minimal inhibitory concentration (range ± 20%) of the underlying pathogen, respectively, of Pseudomonas aeruginosa in empiric situation. Primary outcome was the mean of daily total Sequential Organ Failure Assessment (SOFA) score up to day 10.METHODSRandomized, multicenter, controlled trial from January 2017 to December 2019. Adult patients (n = 254) with sepsis or septic shock were randomly assigned 1:1 to receive continuous infusion of piperacillin/tazobactam with dosing guided by daily TDM of piperacillin or continuous infusion with a fixed dose (13.5 g/24 h if eGFR ≥ 20 mL/min). Target plasma concentration was four times the minimal inhibitory concentration (range ± 20%) of the underlying pathogen, respectively, of Pseudomonas aeruginosa in empiric situation. Primary outcome was the mean of daily total Sequential Organ Failure Assessment (SOFA) score up to day 10.Among 249 evaluable patients (66.3 ± 13.7 years; female, 30.9%), there was no significant difference in mean SOFA score between patients with TDM (7.9 points; 95% CI 7.1-8.7) and without TDM (8.2 points; 95% CI 7.5-9.0) (p = 0.39). Patients with TDM-guided therapy showed a lower 28-day mortality (21.6% vs. 25.8%, RR 0.8, 95% CI 0.5-1.3, p = 0.44) and a higher rate of clinical (OR 1.9; 95% CI 0.5-6.2, p = 0.30) and microbiological cure (OR 2.4; 95% CI 0.7-7.4, p = 0.12), but these differences did not reach statistical significance. Attainment of target concentration was more common in patients with TDM (37.3% vs. 14.6%, OR 4.5, CI 95%, 2.9-6.9, p < 0.001).RESULTSAmong 249 evaluable patients (66.3 ± 13.7 years; female, 30.9%), there was no significant difference in mean SOFA score between patients with TDM (7.9 points; 95% CI 7.1-8.7) and without TDM (8.2 points; 95% CI 7.5-9.0) (p = 0.39). Patients with TDM-guided therapy showed a lower 28-day mortality (21.6% vs. 25.8%, RR 0.8, 95% CI 0.5-1.3, p = 0.44) and a higher rate of clinical (OR 1.9; 95% CI 0.5-6.2, p = 0.30) and microbiological cure (OR 2.4; 95% CI 0.7-7.4, p = 0.12), but these differences did not reach statistical significance. Attainment of target concentration was more common in patients with TDM (37.3% vs. 14.6%, OR 4.5, CI 95%, 2.9-6.9, p < 0.001).TDM-guided therapy showed no beneficial effect in patients with sepsis and continuous infusion of piperacillin/tazobactam with regard to the mean SOFA score. Larger studies with strategies to ensure optimization of antimicrobial exposure are needed to definitively answer the question.CONCLUSIONTDM-guided therapy showed no beneficial effect in patients with sepsis and continuous infusion of piperacillin/tazobactam with regard to the mean SOFA score. Larger studies with strategies to ensure optimization of antimicrobial exposure are needed to definitively answer the question. Insufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided antibiotic therapy improves outcomes. Randomized, multicenter, controlled trial from January 2017 to December 2019. Adult patients (n = 254) with sepsis or septic shock were randomly assigned 1:1 to receive continuous infusion of piperacillin/tazobactam with dosing guided by daily TDM of piperacillin or continuous infusion with a fixed dose (13.5 g/24 h if eGFR [greater than or equal to] 20 mL/min). Target plasma concentration was four times the minimal inhibitory concentration (range ± 20%) of the underlying pathogen, respectively, of Pseudomonas aeruginosa in empiric situation. Primary outcome was the mean of daily total Sequential Organ Failure Assessment (SOFA) score up to day 10. Among 249 evaluable patients (66.3 ± 13.7 years; female, 30.9%), there was no significant difference in mean SOFA score between patients with TDM (7.9 points; 95% CI 7.1-8.7) and without TDM (8.2 points; 95% CI 7.5-9.0) (p = 0.39). Patients with TDM-guided therapy showed a lower 28-day mortality (21.6% vs. 25.8%, RR 0.8, 95% CI 0.5-1.3, p = 0.44) and a higher rate of clinical (OR 1.9; 95% CI 0.5-6.2, p = 0.30) and microbiological cure (OR 2.4; 95% CI 0.7-7.4, p = 0.12), but these differences did not reach statistical significance. Attainment of target concentration was more common in patients with TDM (37.3% vs. 14.6%, OR 4.5, CI 95%, 2.9-6.9, p < 0.001). TDM-guided therapy showed no beneficial effect in patients with sepsis and continuous infusion of piperacillin/tazobactam with regard to the mean SOFA score. Larger studies with strategies to ensure optimization of antimicrobial exposure are needed to definitively answer the question. Purpose Insufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided antibiotic therapy improves outcomes. Methods Randomized, multicenter, controlled trial from January 2017 to December 2019. Adult patients (n = 254) with sepsis or septic shock were randomly assigned 1:1 to receive continuous infusion of piperacillin/tazobactam with dosing guided by daily TDM of piperacillin or continuous infusion with a fixed dose (13.5 g/24 h if eGFR [greater than or equal to] 20 mL/min). Target plasma concentration was four times the minimal inhibitory concentration (range ± 20%) of the underlying pathogen, respectively, of Pseudomonas aeruginosa in empiric situation. Primary outcome was the mean of daily total Sequential Organ Failure Assessment (SOFA) score up to day 10. Results Among 249 evaluable patients (66.3 ± 13.7 years; female, 30.9%), there was no significant difference in mean SOFA score between patients with TDM (7.9 points; 95% CI 7.1-8.7) and without TDM (8.2 points; 95% CI 7.5-9.0) (p = 0.39). Patients with TDM-guided therapy showed a lower 28-day mortality (21.6% vs. 25.8%, RR 0.8, 95% CI 0.5-1.3, p = 0.44) and a higher rate of clinical (OR 1.9; 95% CI 0.5-6.2, p = 0.30) and microbiological cure (OR 2.4; 95% CI 0.7-7.4, p = 0.12), but these differences did not reach statistical significance. Attainment of target concentration was more common in patients with TDM (37.3% vs. 14.6%, OR 4.5, CI 95%, 2.9-6.9, p < 0.001). Conclusion TDM-guided therapy showed no beneficial effect in patients with sepsis and continuous infusion of piperacillin/tazobactam with regard to the mean SOFA score. Larger studies with strategies to ensure optimization of antimicrobial exposure are needed to definitively answer the question. Purpose Insufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided antibiotic therapy improves outcomes. Methods Randomized, multicenter, controlled trial from January 2017 to December 2019. Adult patients ( n = 254) with sepsis or septic shock were randomly assigned 1:1 to receive continuous infusion of piperacillin/tazobactam with dosing guided by daily TDM of piperacillin or continuous infusion with a fixed dose (13.5 g/24 h if eGFR ≥ 20 mL/min). Target plasma concentration was four times the minimal inhibitory concentration (range ± 20%) of the underlying pathogen, respectively, of Pseudomonas aeruginosa in empiric situation. Primary outcome was the mean of daily total Sequential Organ Failure Assessment (SOFA) score up to day 10. Results Among 249 evaluable patients (66.3 ± 13.7 years; female, 30.9%), there was no significant difference in mean SOFA score between patients with TDM (7.9 points; 95% CI 7.1–8.7) and without TDM (8.2 points; 95% CI 7.5–9.0) ( p = 0.39). Patients with TDM-guided therapy showed a lower 28-day mortality (21.6% vs. 25.8%, RR 0.8, 95% CI 0.5–1.3, p = 0.44) and a higher rate of clinical (OR 1.9; 95% CI 0.5–6.2, p = 0.30) and microbiological cure (OR 2.4; 95% CI 0.7–7.4, p = 0.12), but these differences did not reach statistical significance. Attainment of target concentration was more common in patients with TDM (37.3% vs. 14.6%, OR 4.5, CI 95%, 2.9–6.9, p < 0.001). Conclusion TDM-guided therapy showed no beneficial effect in patients with sepsis and continuous infusion of piperacillin/tazobactam with regard to the mean SOFA score. Larger studies with strategies to ensure optimization of antimicrobial exposure are needed to definitively answer the question. Insufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided antibiotic therapy improves outcomes. Randomized, multicenter, controlled trial from January 2017 to December 2019. Adult patients (n = 254) with sepsis or septic shock were randomly assigned 1:1 to receive continuous infusion of piperacillin/tazobactam with dosing guided by daily TDM of piperacillin or continuous infusion with a fixed dose (13.5 g/24 h if eGFR ≥ 20 mL/min). Target plasma concentration was four times the minimal inhibitory concentration (range ± 20%) of the underlying pathogen, respectively, of Pseudomonas aeruginosa in empiric situation. Primary outcome was the mean of daily total Sequential Organ Failure Assessment (SOFA) score up to day 10. Among 249 evaluable patients (66.3 ± 13.7 years; female, 30.9%), there was no significant difference in mean SOFA score between patients with TDM (7.9 points; 95% CI 7.1-8.7) and without TDM (8.2 points; 95% CI 7.5-9.0) (p = 0.39). Patients with TDM-guided therapy showed a lower 28-day mortality (21.6% vs. 25.8%, RR 0.8, 95% CI 0.5-1.3, p = 0.44) and a higher rate of clinical (OR 1.9; 95% CI 0.5-6.2, p = 0.30) and microbiological cure (OR 2.4; 95% CI 0.7-7.4, p = 0.12), but these differences did not reach statistical significance. Attainment of target concentration was more common in patients with TDM (37.3% vs. 14.6%, OR 4.5, CI 95%, 2.9-6.9, p < 0.001). TDM-guided therapy showed no beneficial effect in patients with sepsis and continuous infusion of piperacillin/tazobactam with regard to the mean SOFA score. Larger studies with strategies to ensure optimization of antimicrobial exposure are needed to definitively answer the question. PurposeInsufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided antibiotic therapy improves outcomes.MethodsRandomized, multicenter, controlled trial from January 2017 to December 2019. Adult patients (n = 254) with sepsis or septic shock were randomly assigned 1:1 to receive continuous infusion of piperacillin/tazobactam with dosing guided by daily TDM of piperacillin or continuous infusion with a fixed dose (13.5 g/24 h if eGFR ≥ 20 mL/min). Target plasma concentration was four times the minimal inhibitory concentration (range ± 20%) of the underlying pathogen, respectively, of Pseudomonas aeruginosa in empiric situation. Primary outcome was the mean of daily total Sequential Organ Failure Assessment (SOFA) score up to day 10.ResultsAmong 249 evaluable patients (66.3 ± 13.7 years; female, 30.9%), there was no significant difference in mean SOFA score between patients with TDM (7.9 points; 95% CI 7.1–8.7) and without TDM (8.2 points; 95% CI 7.5–9.0) (p = 0.39). Patients with TDM-guided therapy showed a lower 28-day mortality (21.6% vs. 25.8%, RR 0.8, 95% CI 0.5–1.3, p = 0.44) and a higher rate of clinical (OR 1.9; 95% CI 0.5–6.2, p = 0.30) and microbiological cure (OR 2.4; 95% CI 0.7–7.4, p = 0.12), but these differences did not reach statistical significance. Attainment of target concentration was more common in patients with TDM (37.3% vs. 14.6%, OR 4.5, CI 95%, 2.9–6.9, p < 0.001).ConclusionTDM-guided therapy showed no beneficial effect in patients with sepsis and continuous infusion of piperacillin/tazobactam with regard to the mean SOFA score. Larger studies with strategies to ensure optimization of antimicrobial exposure are needed to definitively answer the question. |
| Audience | Academic |
| Author | Frey, Otto Kiehntopf, Michael Brenner, Thorsten Nierhaus, Axel Neugebauer, Sophie Kluge, Stefan Bach, Friedhelm Pletz, Mathias W. Müller, Carsten Hagel, Stefan Weigand, Markus Bracht, Hendrik Jarczak, Dominik Brinkmann, Alexander Annecke, Thorsten Witzke, Dominic Hohn, Andreas Weismann, Dirk Lehmann, Thomas Michels, Guido König, Christina Bauer, Michael Roberts, Jason A. |
| Author_xml | – sequence: 1 givenname: Stefan orcidid: 0000-0003-2999-6131 surname: Hagel fullname: Hagel, Stefan email: stefan.hagel@med.uni-jena.de organization: Institute for Infectious Diseases and Infection Control, Jena University Hospital-Friedrich Schiller University Jena, Center for Sepsis Control and Care (CSCC), Jena University Hospital-Friedrich Schiller University Jena – sequence: 2 givenname: Friedhelm surname: Bach fullname: Bach, Friedhelm organization: Department of Infectious Diseases, Evangelisches Klinikum Bethel – sequence: 3 givenname: Thorsten surname: Brenner fullname: Brenner, Thorsten organization: Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, Department of Anesthesiology, Heidelberg University Hospital – sequence: 4 givenname: Hendrik surname: Bracht fullname: Bracht, Hendrik organization: Department of Anaesthesiology and Critical Care Medicine, University Hospital of Ulm – sequence: 5 givenname: Alexander surname: Brinkmann fullname: Brinkmann, Alexander organization: Department of Anaesthesiology and Intensive Care Medicine, General Hospital of Heidenheim – sequence: 6 givenname: Thorsten surname: Annecke fullname: Annecke, Thorsten organization: Department of Anaesthesiology and Intensive Care Medicine, Faculty of Medicine, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Department of Anesthesiology and Intensive Care Medicine, Kliniken der Stadt Köln gGmbH, University of Witten/Herdecke – sequence: 7 givenname: Andreas surname: Hohn fullname: Hohn, Andreas organization: Department of Anaesthesiology and Intensive Care Medicine, Faculty of Medicine, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Department of Anaesthesiology and Intensive Care Medicine, Kliniken Maria Hilf – sequence: 8 givenname: Markus surname: Weigand fullname: Weigand, Markus organization: Department of Anesthesiology, Heidelberg University Hospital – sequence: 9 givenname: Guido surname: Michels fullname: Michels, Guido organization: Department of Acute and Emergency Care, St.-Antonius-Hospital gGmbH – sequence: 10 givenname: Stefan surname: Kluge fullname: Kluge, Stefan organization: Department of Intensive Care Medicine, University Medical Centre Hamburg-Eppendorf – sequence: 11 givenname: Axel surname: Nierhaus fullname: Nierhaus, Axel organization: Department of Intensive Care Medicine, University Medical Centre Hamburg-Eppendorf – sequence: 12 givenname: Dominik surname: Jarczak fullname: Jarczak, Dominik organization: Department of Intensive Care Medicine, University Medical Centre Hamburg-Eppendorf – sequence: 13 givenname: Christina surname: König fullname: König, Christina organization: Department of Intensive Care Medicine, University Medical Centre Hamburg-Eppendorf – sequence: 14 givenname: Dirk surname: Weismann fullname: Weismann, Dirk organization: Medizinische Klinik Und Poliklinik I, Internistische Notfall- und Intensivmedizin, Universitätsklinikum Würzburg – sequence: 15 givenname: Otto surname: Frey fullname: Frey, Otto organization: Department of Pharmacy, General Hospital of Heidenheim – sequence: 16 givenname: Dominic surname: Witzke fullname: Witzke, Dominic organization: Department of Infectious Diseases, Evangelisches Klinikum Bethel – sequence: 17 givenname: Carsten surname: Müller fullname: Müller, Carsten organization: Centre of Pharmacology, Department of Therapeutic Drug Monitoring, University Hospital of Cologne – sequence: 18 givenname: Michael surname: Bauer fullname: Bauer, Michael organization: Department of Anesthesiology and Intensive Care Therapy, Jena University Hospital-Friedrich Schiller University Jena – sequence: 19 givenname: Michael surname: Kiehntopf fullname: Kiehntopf, Michael organization: Department of Clinical Chemistry and Laboratory Medicine, Jena University Hospital-Friedrich Schiller University Jena – sequence: 20 givenname: Sophie surname: Neugebauer fullname: Neugebauer, Sophie organization: Center for Sepsis Control and Care (CSCC), Jena University Hospital-Friedrich Schiller University Jena, Department of Clinical Chemistry and Laboratory Medicine, Jena University Hospital-Friedrich Schiller University Jena – sequence: 21 givenname: Thomas surname: Lehmann fullname: Lehmann, Thomas organization: Institute of Medical Statistics, Computer Sciences and Data Sciences, Jena University Hospital-Friedrich Schiller University Jena – sequence: 22 givenname: Jason A. surname: Roberts fullname: Roberts, Jason A. organization: University of Queensland Centre for Clinical Research, and School of Pharmacy, University of Queensland, Department of Intensive Care Medicine and Pharmacy Department, Royal Brisbane and Women’s Hospital, Division of Anaesthesiology Critical Care Emergency and Pain Medicine, Nîmes University Hospital, University of Montpellier – sequence: 23 givenname: Mathias W. surname: Pletz fullname: Pletz, Mathias W. organization: Institute for Infectious Diseases and Infection Control, Jena University Hospital-Friedrich Schiller University Jena, Center for Sepsis Control and Care (CSCC), Jena University Hospital-Friedrich Schiller University Jena |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/35106617$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1097/00007691-199902000-00010 10.1093/cid/ciaa303 10.1093/jac/dkx427 10.1007/s00134-021-06506-y 10.1093/jac/dkv201 10.1128/aac.02571-19 10.1186/cc9091 10.1093/jac/dkv123 10.1093/jac/dkx541 10.1016/j.jcrc.2018.08.026 10.1164/rccm.201601-0024OC 10.1001/jama.2012.5833 10.1016/j.clinthera.2017.06.008 10.3205/000103 10.1007/s001340100909 10.1016/j.ijantimicag.2010.06.008 10.1093/cid/ciu027 10.1016/j.jcrc.2019.04.013 10.1007/s00134-020-06050-1 10.1007/s15010-019-01352-z 10.1086/510590 10.1007/s00134-013-3187-2 10.1001/jama.2016.0287 10.1186/s13063-019-3437-x 10.1007/s001340050931 |
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| Contributor | Richter, Daniel Angermair, Stefan Röhr, Anka Bloos, Frank Hüter, Lars Schmidt, Karsten Schlattmann, Peter Deja, Maria Kurlbaum, Max Braune, Anke Pinder, Nadine Gründling, Matthias Motsch, Johann Fiedler, Sandra Chkirni, Hicham Ameln-Mayerhofer von, Andreas Fuchs, Thomas Schreiner, Oliver Schappacher, Markus |
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Insufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided... Insufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided antibiotic... Purpose Insufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided... PurposeInsufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided... |
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| SubjectTerms | Adult Anesthesiology Anti-Bacterial Agents - therapeutic use Antibiotics Antiinfectives and antibacterials Care and treatment Clinical trials Critical Care Medicine Dosage Drug dosages Drug Monitoring Emergency Medicine Evaluation Female Health aspects Health care industry Humans Infection Intensive Intensive care Medicine Medicine & Public Health Monitoring Multiple Organ Failure Optimization Original Pain Medicine Patients Pediatrics Penicillanic Acid Piperacillin Piperacillin - therapeutic use Piperacillin, Tazobactam Drug Combination - therapeutic use Pneumology/Respiratory System Pseudomonas aeruginosa Sepsis Sepsis - complications Sepsis - drug therapy Septic shock Tazobactam Therapeutic drug monitoring Therapy |
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| Title | Effect of therapeutic drug monitoring-based dose optimization of piperacillin/tazobactam on sepsis-related organ dysfunction in patients with sepsis: a randomized controlled trial |
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