Observational Study

. 2025 Sep;51(9):1628-1640.

doi: 10.1007/s00134-025-08067-w. Epub 2025 Aug 13.

Meropenem and piperacillin/tazobactam optimised dosing regimens for critically ill patients receiving renal replacement therapy

Jason A Roberts^#^{1

2

3

4

5}, Marta Ulldemolins^#⁶, Xin Liu⁶, João P Baptista⁷, Irma Bilgrami⁸, Clement Boidin^{6

9

10}, Alexander Brinkmann¹¹, Pedro Castro^{12

13}, Gordon Choi¹⁴, Louise Cole^{15

16}, Jan J De Waele^{17

18}, Renae Deans⁶, Sine Donnellan¹⁹, Glenn M Eastwood²⁰, Otto R Frey²¹, Sylvain Goutelle^{9

10}, Rebecca Gresham¹⁶, Janattul Ain Jamal²², Gavin M Joynt¹⁴, Salmaan Kanji^{23

24}, Stefan Kluge²⁵, Christina König^{25

26}, Vasilios P Koulouras²⁷, Melissa Lassig-Smith²⁸, Pierre-Francois Laterre²⁹, Anna Lee¹⁴, Jean-Yves Lefrant³⁰, Katie Lei³¹, Patricia Leung¹⁴, Mireia Llaurado-Serra³², Ignacio Martin-Loeches^{33

34}, Mohd Basri Mat Nor³⁵, Yugan Mudaliar³⁶, Marlies Ostermann³¹, Sanjoy K Paul³⁷, Sandra L Peake^{38

39

40}, Jordi Rello^{30

41

42}, Darren M Roberts^{43

44}, Michael S Roberts^{45

46

47}, Brent Richards⁴⁸, Alejandro Rodríguez^{42

49

50

51}, Anka C Roehr²¹, Claire Roger³⁰, Leonardo Seoane^{52

53

54}, Mahipal Sinnollareddy^{45

46}, Eduardo Sousa⁷, Dolors Soy^{13

55

56}, Anna Spring⁵⁷, Therese Starr²⁸, Dianne Stephens^{8

58

59}, Fabio Silvio Taccone⁶⁰, Jane Thomas⁸, John Turnidge⁶¹, Miia Valkonen⁶², Julie M Varghese⁶, Steven C Wallis⁶, Robert J Walker^{19

63}, Tricia Williams^{38

39

40}, Luke C Wilson⁶³, Xavier Wittebole²⁹, Daniel F B Wright^{64

65

66}, Xanthi T Zikou⁶⁷, Rinaldo Bellomo^{20

68

69

70

71}, Jeffrey Lipman^{6

28

30

72}; SMARRT Study Collaborators

Collaborators, Affiliations

Collaborators

Affiliations

¹ University of Queensland Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Royal Brisbane and Women's Hospital Campus, Herston, Brisbane, Australia. j.roberts@uq.edu.au.
² Herston Infectious Diseases Institute (HeIDI), Metro North Health, Brisbane, Australia. j.roberts@uq.edu.au.
³ Department of Pharmacy, Royal Brisbane and Women's Hospital, Brisbane, Australia. j.roberts@uq.edu.au.
⁴ Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia. j.roberts@uq.edu.au.
⁵ Division of Anesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, UR-UM103 IMAGINE, Universite Montpellier, Montpellier, France. j.roberts@uq.edu.au.
⁶ University of Queensland Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Royal Brisbane and Women's Hospital Campus, Herston, Brisbane, Australia.
⁷ Intensive Care Medicine Department, Hospitais da Universidade de Coimbra (HUC), ULS Coimbra, Coimbra, Portugal.
⁸ Intensive Care Unit, Royal Darwin Hospital, Tiwi, NT, Australia.
⁹ Laboratoire de Biométrie et Biologie Évolutive, Université Claude Bernard Lyon 1, UMR CNRS 5558, Lyon, France.
¹⁰ Service de Pharmacie, GH Nord, Hospices Civils de Lyon, Lyon, France.
¹¹ Department of Anesthesia and Critical Care Medicine, General Hospital of Heidenheim, Heidenheim, Germany.
¹² Medical Intensive Care Unit, Institut Clínic de Medicina I Dermatologia, Hospital Clínic de Barcelona, Barcelona, Spain.
¹³ Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
¹⁴ Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, Hong Kong.
¹⁵ School of Medicine, University of Sydney, Sydney, Australia.
¹⁶ Intensive Care Unit, Nepean Hospital, Sydney, Australia.
¹⁷ Department of Intensive Care Medicine, Ghent University Hospital, Ghent, Belgium.
¹⁸ Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
¹⁹ Department of Nephrology, Dunedin Public Hospital, Dunedin, New Zealand.
²⁰ Department of Intensive Care, Austin Hospital, Heidelberg, Australia.
²¹ Department of Pharmacy, General Hospital of Heidenheim, Heidenheim, Germany.
²² Department of Clinical Pharmacy, Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Malaysia.
²³ Department of Pharmacy, The Ottawa Hospital, Ottawa, Canada.
²⁴ The Ottawa Hospital Research Institute, Ottawa, Canada.
²⁵ Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
²⁶ Hospital Pharmacy, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
²⁷ Intensive Care Unit Department, University Hospital of Ioannina, Ioannina, Greece.
²⁸ Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.
²⁹ Intensive Care Unit, Clinique Universitaire St Luc, UCLouvain, Brussels, Belgium.
³⁰ Division of Anesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, UR-UM103 IMAGINE, Universite Montpellier, Montpellier, France.
³¹ Guy's and St Thomas Hospital, London, UK.
³² Department of Fundamental and Clinical Care Nursing, Faculty of Nursing, Bellvitge Campus, University of Barcelona, Barcelona, Spain.
³³ Multidisciplinary Intensive Care Research Organization (MICRO), St James Hospital, Dublin, Ireland.
³⁴ School of Medicine, Trinity College Dublin, Dublin, Ireland.
³⁵ Kulliyyah of Medicine, International Islamic University Malaysia, Kuantan Campus, Kuantan, Pahang, Malaysia.
³⁶ Critical Care Intensive Care Unit Services, Westmead Public/Private Hospitals, Sydney, Australia.
³⁷ College of Life Sciences, University of Leicester, Leicester, UK.
³⁸ Department of Intensive Care Medicine, The Queen Elizabeth Hospital, Woodville, Australia.
³⁹ Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.
⁴⁰ School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.
⁴¹ Clinical Research in Pneumonia and Sepsis, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain.
⁴² Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.
⁴³ New South Wales Poisons Information Centre, Sydney Children's Hospitals Network, Westmead, Australia.
⁴⁴ Edith Collins Centre, Drug Health Services, Royal Prince Alfred Hospital, Camperdown, Australia.
⁴⁵ Therapeutics Research Centre, UQCCR and Frazer Institute, Faculty of Medicine, The University of Queensland, Brisbane, Australia.
⁴⁶ UniSA Clinical and Health Sciences, University of South Australia, Adelaide, Australia.
⁴⁷ Therapeutics Research Centre, Basil Hetzel Institute for Translational Medical Research, The Queen Elizabeth Hospital, Adelaide, Australia.
⁴⁸ Intensive Care Unit, Gold Coast University Hospital, Gold Coast, Australia.
⁴⁹ Critical Care Department, Hospital Universitari Joan XXIII, Tarragona, Spain.
⁵⁰ Faculty of Medicine, Universitat Rovira i Virgili, Tarragona, Spain.
⁵¹ Pere Virgili Health Research Institute, Tarragona, Spain.
⁵² Faculty of Medicine, The University of Queensland, New Orleans, USA.
⁵³ Intensive Care Unit, Ochsner Health System, New Orleans, USA.
⁵⁴ University of Queensland Ochsner Clinical School, New Orleans, USA.
⁵⁵ Pharmacy Department, Division of Medicines, Hospital Clínic de Barcelona, Barcelona, Spain.
⁵⁶ Department of Pharmacology, Toxicology and Therapeutic Chemistry-School of Pharmacy, University of Barcelona, Barcelona, Spain.
⁵⁷ Intensive Care Unit, Naval and Veterans Hospital of Athens, Athens, Greece.
⁵⁸ CDU Menzies School of Medicine, Charles Darwin University, Casuarina, Australia.
⁵⁹ National Critical Care and Trauma Response Centre, Darwin, Australia.
⁶⁰ Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB), Université Libre de Bruxelles (ULB), Brussels, Belgium.
⁶¹ School of Biological Sciences, University of Adelaide, Adelaide, Australia.
⁶² Intensive Care Medicine, Department of Perioperative, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
⁶³ Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
⁶⁴ Sydney Pharmacy School, University of Sydney, Sydney, Australia.
⁶⁵ Department of Clinical Pharmacology and Toxicology, St Vincent's Hospital Sydney, Darlinghurst, Australia.
⁶⁶ St Vincent's Clinical Campus, UNSW Medicine, Sydney, Australia.
⁶⁷ Intensive Care Unit Department, Army Share Fund Hospital Athens, Athens, Greece.
⁶⁸ Department of Critical Care, Melbourne Medical School, University of Melbourne, Parkville, Australia.
⁶⁹ Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Australia.
⁷⁰ Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
⁷¹ Data Analytics Research and Evaluation Centre, Austin Hospital, Melbourne, Australia.
⁷² Jamieson Trauma Institute, Royal Brisbane and Women's Hospital, Brisbane, Australia.

^# Contributed equally.

PMID: 40801954
PMCID: PMC12405346
DOI: 10.1007/s00134-025-08067-w

Observational Study

Meropenem and piperacillin/tazobactam optimised dosing regimens for critically ill patients receiving renal replacement therapy

Jason A Roberts et al. Intensive Care Med. 2025 Sep.

. 2025 Sep;51(9):1628-1640.

doi: 10.1007/s00134-025-08067-w. Epub 2025 Aug 13.

Authors

Collaborators

Affiliations

¹ University of Queensland Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Royal Brisbane and Women's Hospital Campus, Herston, Brisbane, Australia. j.roberts@uq.edu.au.
² Herston Infectious Diseases Institute (HeIDI), Metro North Health, Brisbane, Australia. j.roberts@uq.edu.au.
³ Department of Pharmacy, Royal Brisbane and Women's Hospital, Brisbane, Australia. j.roberts@uq.edu.au.
⁴ Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia. j.roberts@uq.edu.au.
⁵ Division of Anesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, UR-UM103 IMAGINE, Universite Montpellier, Montpellier, France. j.roberts@uq.edu.au.
⁶ University of Queensland Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Royal Brisbane and Women's Hospital Campus, Herston, Brisbane, Australia.
⁷ Intensive Care Medicine Department, Hospitais da Universidade de Coimbra (HUC), ULS Coimbra, Coimbra, Portugal.
⁸ Intensive Care Unit, Royal Darwin Hospital, Tiwi, NT, Australia.
⁹ Laboratoire de Biométrie et Biologie Évolutive, Université Claude Bernard Lyon 1, UMR CNRS 5558, Lyon, France.
¹⁰ Service de Pharmacie, GH Nord, Hospices Civils de Lyon, Lyon, France.
¹¹ Department of Anesthesia and Critical Care Medicine, General Hospital of Heidenheim, Heidenheim, Germany.
¹² Medical Intensive Care Unit, Institut Clínic de Medicina I Dermatologia, Hospital Clínic de Barcelona, Barcelona, Spain.
¹³ Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
¹⁴ Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, Hong Kong.
¹⁵ School of Medicine, University of Sydney, Sydney, Australia.
¹⁶ Intensive Care Unit, Nepean Hospital, Sydney, Australia.
¹⁷ Department of Intensive Care Medicine, Ghent University Hospital, Ghent, Belgium.
¹⁸ Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
¹⁹ Department of Nephrology, Dunedin Public Hospital, Dunedin, New Zealand.
²⁰ Department of Intensive Care, Austin Hospital, Heidelberg, Australia.
²¹ Department of Pharmacy, General Hospital of Heidenheim, Heidenheim, Germany.
²² Department of Clinical Pharmacy, Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Malaysia.
²³ Department of Pharmacy, The Ottawa Hospital, Ottawa, Canada.
²⁴ The Ottawa Hospital Research Institute, Ottawa, Canada.
²⁵ Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
²⁶ Hospital Pharmacy, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
²⁷ Intensive Care Unit Department, University Hospital of Ioannina, Ioannina, Greece.
²⁸ Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.
²⁹ Intensive Care Unit, Clinique Universitaire St Luc, UCLouvain, Brussels, Belgium.
³⁰ Division of Anesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, UR-UM103 IMAGINE, Universite Montpellier, Montpellier, France.
³¹ Guy's and St Thomas Hospital, London, UK.
³² Department of Fundamental and Clinical Care Nursing, Faculty of Nursing, Bellvitge Campus, University of Barcelona, Barcelona, Spain.
³³ Multidisciplinary Intensive Care Research Organization (MICRO), St James Hospital, Dublin, Ireland.
³⁴ School of Medicine, Trinity College Dublin, Dublin, Ireland.
³⁵ Kulliyyah of Medicine, International Islamic University Malaysia, Kuantan Campus, Kuantan, Pahang, Malaysia.
³⁶ Critical Care Intensive Care Unit Services, Westmead Public/Private Hospitals, Sydney, Australia.
³⁷ College of Life Sciences, University of Leicester, Leicester, UK.
³⁸ Department of Intensive Care Medicine, The Queen Elizabeth Hospital, Woodville, Australia.
³⁹ Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.
⁴⁰ School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.
⁴¹ Clinical Research in Pneumonia and Sepsis, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain.
⁴² Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.
⁴³ New South Wales Poisons Information Centre, Sydney Children's Hospitals Network, Westmead, Australia.
⁴⁴ Edith Collins Centre, Drug Health Services, Royal Prince Alfred Hospital, Camperdown, Australia.
⁴⁵ Therapeutics Research Centre, UQCCR and Frazer Institute, Faculty of Medicine, The University of Queensland, Brisbane, Australia.
⁴⁶ UniSA Clinical and Health Sciences, University of South Australia, Adelaide, Australia.
⁴⁷ Therapeutics Research Centre, Basil Hetzel Institute for Translational Medical Research, The Queen Elizabeth Hospital, Adelaide, Australia.
⁴⁸ Intensive Care Unit, Gold Coast University Hospital, Gold Coast, Australia.
⁴⁹ Critical Care Department, Hospital Universitari Joan XXIII, Tarragona, Spain.
⁵⁰ Faculty of Medicine, Universitat Rovira i Virgili, Tarragona, Spain.
⁵¹ Pere Virgili Health Research Institute, Tarragona, Spain.
⁵² Faculty of Medicine, The University of Queensland, New Orleans, USA.
⁵³ Intensive Care Unit, Ochsner Health System, New Orleans, USA.
⁵⁴ University of Queensland Ochsner Clinical School, New Orleans, USA.
⁵⁵ Pharmacy Department, Division of Medicines, Hospital Clínic de Barcelona, Barcelona, Spain.
⁵⁶ Department of Pharmacology, Toxicology and Therapeutic Chemistry-School of Pharmacy, University of Barcelona, Barcelona, Spain.
⁵⁷ Intensive Care Unit, Naval and Veterans Hospital of Athens, Athens, Greece.
⁵⁸ CDU Menzies School of Medicine, Charles Darwin University, Casuarina, Australia.
⁵⁹ National Critical Care and Trauma Response Centre, Darwin, Australia.
⁶⁰ Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB), Université Libre de Bruxelles (ULB), Brussels, Belgium.
⁶¹ School of Biological Sciences, University of Adelaide, Adelaide, Australia.
⁶² Intensive Care Medicine, Department of Perioperative, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
⁶³ Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
⁶⁴ Sydney Pharmacy School, University of Sydney, Sydney, Australia.
⁶⁵ Department of Clinical Pharmacology and Toxicology, St Vincent's Hospital Sydney, Darlinghurst, Australia.
⁶⁶ St Vincent's Clinical Campus, UNSW Medicine, Sydney, Australia.
⁶⁷ Intensive Care Unit Department, Army Share Fund Hospital Athens, Athens, Greece.
⁶⁸ Department of Critical Care, Melbourne Medical School, University of Melbourne, Parkville, Australia.
⁶⁹ Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Australia.
⁷⁰ Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
⁷¹ Data Analytics Research and Evaluation Centre, Austin Hospital, Melbourne, Australia.
⁷² Jamieson Trauma Institute, Royal Brisbane and Women's Hospital, Brisbane, Australia.

^# Contributed equally.

PMID: 40801954
PMCID: PMC12405346
DOI: 10.1007/s00134-025-08067-w

Abstract

Purpose: Optimal dosing of meropenem and piperacillin/tazobactam in critically ill patients receiving renal replacement therapy (RRT) is uncertain due to variable pharmacokinetics. We aimed to develop generalisable optimised dosing recommendations for these antibiotics.

Methods: Prospective, multinational pharmacokinetic study including patients requiring various forms of RRT. Independent population PK models were developed, externally validated and applied to perform Monte Carlo dosing simulations using Monolix and Simulx. We calculated the probability that these dosing regimens achieved standard and high therapeutic unbound antibiotic concentrations over 100% of the dosing interval for the treatment of Enterobacterales and Pseudomonas aeruginosa.

Results: We enrolled 300 patients from 22 intensive care units across 12 countries receiving continuous veno-venous haemodialysis (13.0%), haemofiltration (23.3%), haemodiafiltration (48.4%) or sustained low-efficiency dialysis (15.3%). Models were developed using data from 234 patients (8322 samples) and validated with 66 additional patients (560 samples). Predictive performance was high, with mean prediction errors of - 5.2% for meropenem and - 16.9% for piperacillin. Dosing simulations showed that meropenem and piperacillin/tazobactam dosing requirements were dependent on urine output and RRT intensity and duration (p < 0.05). In all scenarios, extended/continuous infusions led to a better achievement of effective concentrations with lower daily doses compared to short infusion. Dosing nomograms were developed to inform dosing for different RRT settings, urine outputs, and target concentrations.

Conclusion: RRT intensity and duration and urine output determine meropenem and piperacillin/tazobactam dosing requirements in critically ill patients receiving RRT. Extended/continuous infusions facilitate the attainment of effective concentrations.

Keywords: Critically ill patients; Dosing nomograms; Meropenem; Pharmacokinetics; Piperacillin/tazobactam; Renal replacement therapy.

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Conflict of interest statement

Declarations. Conflicts of interest: JAR acknowledges consultancies, grant or speaking fees from Sandoz, Qpex, Gilead, Advanz Pharma, Pfizer, MSD, and Biomerieux. CK reports honoraria for speaking/advisory boards from Shionogi and Gilead. SK received research support from CytoSorbents and Daiichi Sankyo. SK also received lecture fees from ADVITOS, Biotest, Daiichi Sankyo, Fresenius Medical Care, Gilead, Mitsubishi Tanabe Pharma, MSD, Pfizer, Shionogi, and ZOLL. SK received consultant fees from Fresenius Medical Care, Gilead, MSD, and Pfizer. MO received research funding from Biomerieux and Baxter (paid to institution). CR received speaker fees from MSD, Pfizer, Shionogi, AOP Orphan, bioMérieux, and Advanz Pharma. CR received fees as Advisory Board member from Advanz Pharma, bioMérieux, and Viatris. JDW has consulted for Biomerieux, Menarini, MSD, Pfizer, Roche Diagnostics, ThermoFisher, and Viatris (fees and honoraria paid to institution). Ethics approval: The study was designed and conducted following the declaration of Helsinki guidelines and received ethics approval from the Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC/13/QRBW/1) as the lead site. All other participating sites also obtained individual HREC approval. In memoriam: The authors would like to acknowledge and honour the extraordinary contribution of Professor Rinaldo Bellomo not only to this project but to the broader field of medical research dedicated to the care of the critically ill patient. His exceptional career in clinical practise, research, and mentorship has resulted in major advancements in intensive care medicine and has profoundly impacted the careers and lives of many healthcare professionals around the globe. With the present work, we would like to pay tribute to his unique individual.

Figures

**Fig. 1**
Schematic algorithm illustrating the dose decision-making process based on the primary determinants of meropenem and piperacillin/tazobactam dosing requirements, using the dosing nomograms

See this image and copyright information in PMC

References

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Meropenem and piperacillin/tazobactam optimised dosing regimens for critically ill patients receiving renal replacement therapy

Collaborators

Affiliations

Meropenem and piperacillin/tazobactam optimised dosing regimens for critically ill patients receiving renal replacement therapy

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

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