The effect of a loading dose of meropenem on outcomes of patients with sepsis treated by continuous renal replacement: study protocol for a randomized controlled trial
Abstract Background Sepsis and continuous renal replacement therapy (CRRT) are both responsible for the alterations of the pharmacokinetics of antibiotics. For patients with sepsis receiving CRRT, the serum concentrations of meropenem in the early phase (< 48 h) was significantly lower than that...
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BMC
2022-04-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06264-2 |
| _version_ | 1818273582903459840 |
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| author | Sui-Qing Ni Wen-Bing Teng Yong-Hong Fu Wei Su Zhi Yang Jie Cai Jin-Nuo Xu Xiao-Ying Deng Xiang-Fang Liu Sheng-Nan Fu Jun Zeng Chen Zhang |
| author_facet | Sui-Qing Ni Wen-Bing Teng Yong-Hong Fu Wei Su Zhi Yang Jie Cai Jin-Nuo Xu Xiao-Ying Deng Xiang-Fang Liu Sheng-Nan Fu Jun Zeng Chen Zhang |
| author_sort | Sui-Qing Ni |
| collection | DOAJ |
| description | Abstract Background Sepsis and continuous renal replacement therapy (CRRT) are both responsible for the alterations of the pharmacokinetics of antibiotics. For patients with sepsis receiving CRRT, the serum concentrations of meropenem in the early phase (< 48 h) was significantly lower than that in the late phase (> 48 h). This current trial aimed to investigate whether administration of a loading dose of meropenem results in a more likely achievement of the pharmacokinetic (PK)/pharmacodynamics (PD) target (100% fT > 4 × MIC) and better therapeutic results in the patients with sepsis receiving CRRT. Methods This is a single-blinded, single-center, randomized, controlled, two-arm, and parallel-group trial. This trial will be carried out in Guangzhou First People’s Hospital, School of Medicine, South China University of Technology Guangdong, China. Adult patients (age ≥ 18 years) with critical sepsis or sepsis-related shock receiving CRRT will be included in the study. The subjects will be assigned to the control group and the intervention group (LD group) randomly at a 1:1 ratio, the estimated sample size should be 120 subjects in each group. In the LD group, the patient will receive a loading dose of 1.5-g meropenem resolved in 30-ml saline which is given via central line for 30 min. Afterward, 0.75-g meropenem will be given immediately for 30 min every 8 h. In the control group, the patient will receive 0.75-g meropenem for 30 min every 8 h. The primary objective is the probabilities of PK/PD target (100% fT > 4 × MIC) achieved in the septic patients who receive CRRT in the first 48 h. Secondary objectives include clinical cure rate, bacterial clearance rate, sepsis-related mortality and all-cause mortality, the total dose of meropenem, duration of meropenem treatment, duration of CRRT, Sequential Organ Failure Assessment (SOFA), C-reactive protein levels, procalcitonin levels, white blood cell count, and safety. Discussion This trial will assess for the first time whether administration of a loading dose of meropenem results in a more likely achievement of the PK/PD target and better therapeutic results in the patients with sepsis receiving CRRT. Since CRRT is an important therapeutic strategy for sepsis patients with hemodynamic instability, the results from this trial may help to provide evidence-based therapy for septic patients receiving CRRT. Trial registration Chinese Clinical Trials Registry, ChiCTR2000032865 . Registered on 13 May 2020, http://www.chictr.org.cn/showproj.aspx?proj=53616 . |
| first_indexed | 2024-12-12T22:00:16Z |
| format | Article |
| id | doaj.art-b5a4688fd03c4745a88d9ae0227c36ad |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T22:00:16Z |
| publishDate | 2022-04-01 |
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| spelling | doaj.art-b5a4688fd03c4745a88d9ae0227c36ad2022-12-22T00:10:33ZengBMCTrials1745-62152022-04-012311810.1186/s13063-022-06264-2The effect of a loading dose of meropenem on outcomes of patients with sepsis treated by continuous renal replacement: study protocol for a randomized controlled trialSui-Qing Ni0Wen-Bing Teng1Yong-Hong Fu2Wei Su3Zhi Yang4Jie Cai5Jin-Nuo Xu6Xiao-Ying Deng7Xiang-Fang Liu8Sheng-Nan Fu9Jun Zeng10Chen Zhang11Department of Pharmacy, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyDepartment of Pharmacy, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyDepartment of Critical Care Medicine, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyDepartment of Critical Care Medicine, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyDepartment of Critical Care Medicine, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyDepartment of Pharmacy, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyDepartment of Pharmacy, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyDepartment of Pharmacy, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyDepartment of Pharmacy, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyDepartment of Pharmacy, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyDepartment of Critical Care Medicine, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyDepartment of Pharmacy, Guangzhou First People’s Hospital, School of Medicine, South China University of TechnologyAbstract Background Sepsis and continuous renal replacement therapy (CRRT) are both responsible for the alterations of the pharmacokinetics of antibiotics. For patients with sepsis receiving CRRT, the serum concentrations of meropenem in the early phase (< 48 h) was significantly lower than that in the late phase (> 48 h). This current trial aimed to investigate whether administration of a loading dose of meropenem results in a more likely achievement of the pharmacokinetic (PK)/pharmacodynamics (PD) target (100% fT > 4 × MIC) and better therapeutic results in the patients with sepsis receiving CRRT. Methods This is a single-blinded, single-center, randomized, controlled, two-arm, and parallel-group trial. This trial will be carried out in Guangzhou First People’s Hospital, School of Medicine, South China University of Technology Guangdong, China. Adult patients (age ≥ 18 years) with critical sepsis or sepsis-related shock receiving CRRT will be included in the study. The subjects will be assigned to the control group and the intervention group (LD group) randomly at a 1:1 ratio, the estimated sample size should be 120 subjects in each group. In the LD group, the patient will receive a loading dose of 1.5-g meropenem resolved in 30-ml saline which is given via central line for 30 min. Afterward, 0.75-g meropenem will be given immediately for 30 min every 8 h. In the control group, the patient will receive 0.75-g meropenem for 30 min every 8 h. The primary objective is the probabilities of PK/PD target (100% fT > 4 × MIC) achieved in the septic patients who receive CRRT in the first 48 h. Secondary objectives include clinical cure rate, bacterial clearance rate, sepsis-related mortality and all-cause mortality, the total dose of meropenem, duration of meropenem treatment, duration of CRRT, Sequential Organ Failure Assessment (SOFA), C-reactive protein levels, procalcitonin levels, white blood cell count, and safety. Discussion This trial will assess for the first time whether administration of a loading dose of meropenem results in a more likely achievement of the PK/PD target and better therapeutic results in the patients with sepsis receiving CRRT. Since CRRT is an important therapeutic strategy for sepsis patients with hemodynamic instability, the results from this trial may help to provide evidence-based therapy for septic patients receiving CRRT. Trial registration Chinese Clinical Trials Registry, ChiCTR2000032865 . Registered on 13 May 2020, http://www.chictr.org.cn/showproj.aspx?proj=53616 .https://doi.org/10.1186/s13063-022-06264-2SepsisContinuous renal replacement therapy (CRRT)MeropenemLoading dosePharmacokinetic (PK)/pharmacodynamics (PD) targetClinical cure rate |
| spellingShingle | Sui-Qing Ni Wen-Bing Teng Yong-Hong Fu Wei Su Zhi Yang Jie Cai Jin-Nuo Xu Xiao-Ying Deng Xiang-Fang Liu Sheng-Nan Fu Jun Zeng Chen Zhang The effect of a loading dose of meropenem on outcomes of patients with sepsis treated by continuous renal replacement: study protocol for a randomized controlled trial Trials Sepsis Continuous renal replacement therapy (CRRT) Meropenem Loading dose Pharmacokinetic (PK)/pharmacodynamics (PD) target Clinical cure rate |
| title | The effect of a loading dose of meropenem on outcomes of patients with sepsis treated by continuous renal replacement: study protocol for a randomized controlled trial |
| title_full | The effect of a loading dose of meropenem on outcomes of patients with sepsis treated by continuous renal replacement: study protocol for a randomized controlled trial |
| title_fullStr | The effect of a loading dose of meropenem on outcomes of patients with sepsis treated by continuous renal replacement: study protocol for a randomized controlled trial |
| title_full_unstemmed | The effect of a loading dose of meropenem on outcomes of patients with sepsis treated by continuous renal replacement: study protocol for a randomized controlled trial |
| title_short | The effect of a loading dose of meropenem on outcomes of patients with sepsis treated by continuous renal replacement: study protocol for a randomized controlled trial |
| title_sort | effect of a loading dose of meropenem on outcomes of patients with sepsis treated by continuous renal replacement study protocol for a randomized controlled trial |
| topic | Sepsis Continuous renal replacement therapy (CRRT) Meropenem Loading dose Pharmacokinetic (PK)/pharmacodynamics (PD) target Clinical cure rate |
| url | https://doi.org/10.1186/s13063-022-06264-2 |
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