Efficacy and safety of heart rate control with esmolol on the incidence and duration of organ failure in predicted severe acute pancreatitis: protocol of a multicenter, open-label, randomized controlled trial
IntroductionOveractivation of the sympathetic nerve system can lead to a sustained increase in heart rate, which may impair blood perfusion and organ function. Previous studies have demonstrated that the use of β-blockers like esmolol can reduce heart rate, thereby improving clinical outcomes in pat...
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2025-07-01
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| author | Mingfeng Huang Rong Wei Lu Ke Weijian Li Jian Song Haibin Ni Xiaofei Huang Yun Sun Lu Fu Yanhua Li Dong Zhang Bin Han Jing Zhang Yingying Hu Chong Zhang Zhongyan Sheng Wenwen Feng Lin Gao Wenjian Mao Yuxiu Liu Yuxiu Liu Bo Ye Zhihui Tong Weiqin Li |
| author_facet | Mingfeng Huang Rong Wei Lu Ke Weijian Li Jian Song Haibin Ni Xiaofei Huang Yun Sun Lu Fu Yanhua Li Dong Zhang Bin Han Jing Zhang Yingying Hu Chong Zhang Zhongyan Sheng Wenwen Feng Lin Gao Wenjian Mao Yuxiu Liu Yuxiu Liu Bo Ye Zhihui Tong Weiqin Li |
| author_sort | Mingfeng Huang |
| collection | DOAJ |
| description | IntroductionOveractivation of the sympathetic nerve system can lead to a sustained increase in heart rate, which may impair blood perfusion and organ function. Previous studies have demonstrated that the use of β-blockers like esmolol can reduce heart rate, thereby improving clinical outcomes in patients with septic shock. For acute pancreatitis (AP), which shares a similar inflammatory pathophysiology with sepsis, previous experimental and observational studies showed significant sympathetic excitation during the acute phase, and the use of β-blockers might be clinically beneficial. This study aims to test the hypothesis that early intravenous esmolol administration to control heart rate will improve the incidence and duration of organ failure in patients with predicted severe acute pancreatitis (pSAP).MethodsThis is an investigator-initiated, multicenter, open-label, randomized controlled trial. All patients with pSAP who still exhibit elevated heart rate (≥110 bpm) after 6 h of adequate intravenous fluid resuscitation within the first 72 h of symptom onset will be screened for eligibility. A total of 146 participants will be randomized to receive either esmolol or standard care. Patients in the esmolol group will receive a continuous esmolol infusion to maintain a heart rate between 80 and 94 beats per minute (bpm) within the first 96 h of randomization. The primary endpoint is organ failure free and alive days (OFFDs) to day 14 after trial entry. Secondary endpoints are comprised of both process and clinical measures, including heart rate variability, the proportion of patients’ heart rate recovered to <95 bpm, changes in plasma interleukin-6 and C-reactive protein between day 1 and day 5, in hospital and 90-day mortality, new-onset organ failure, free and alive days to day 30 for intensive care admission, and requirement of mechanical ventilation, vasopressor use, and renal replacement therapy.DiscussionThis study will provide top-class evidence concerning the effects of heart rate control with a classic β-blocker on the incidence and duration of organ failure in patients with pSAP and increased heart rate.Ethics and disseminationThis study has been approved by the ethics committee of Jinling Hospital, Nanjing University (2022DZKY-076-02) and all participating sites. Results will be disseminated through peer-reviewed journals and scientific conferences.Trial registrationIdentifier, ChiCTR2400080160. |
| format | Article |
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| institution | Kabale University |
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| publishDate | 2025-07-01 |
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| spelling | doaj-art-a2a602a7a7d84d8dbed2725ff2deca4a2025-08-20T03:34:36ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2025-07-011210.3389/fmed.2025.16427211642721Efficacy and safety of heart rate control with esmolol on the incidence and duration of organ failure in predicted severe acute pancreatitis: protocol of a multicenter, open-label, randomized controlled trialMingfeng Huang0Rong Wei1Lu Ke2Weijian Li3Jian Song4Haibin Ni5Xiaofei Huang6Yun Sun7Lu Fu8Yanhua Li9Dong Zhang10Bin Han11Jing Zhang12Yingying Hu13Chong Zhang14Zhongyan Sheng15Wenwen Feng16Lin Gao17Wenjian Mao18Yuxiu Liu19Yuxiu Liu20Bo Ye21Zhihui Tong22Weiqin Li23Department of Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, ChinaJinling Clinical Medical College, Nanjing Medical University, Nanjing, ChinaDepartment of Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, ChinaThe Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, ChinaThe Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, ChinaAffiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, ChinaAffiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, ChinaThe First Department of Critical Care Medicine, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, ChinaThe First Department of Critical Care Medicine, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, ChinaDepartment of Critical Care Medicine, The First Hospital of Jilin University, Changchun, ChinaDepartment of Critical Care Medicine, The First Hospital of Jilin University, Changchun, ChinaDepartment of Emergency, The First People's Hospital Yunnan Province, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, ChinaDepartment of Emergency, The First People's Hospital Yunnan Province, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, ChinaThe First Affiliated Hospital of Henan University of Science & Technology, Luoyang, Henan, ChinaThe First Affiliated Hospital of Henan University of Science & Technology, Luoyang, Henan, ChinaDepartment of Critical Care Medicine, Qianxinan People's Hospital, Qianxinan, Guizhou, ChinaDepartment of Critical Care Medicine, Qianxinan People's Hospital, Qianxinan, Guizhou, ChinaDepartment of Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, ChinaDepartment of Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, ChinaDepartment of Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China0Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, ChinaDepartment of Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, ChinaJinling Clinical Medical College, Nanjing Medical University, Nanjing, ChinaDepartment of Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, ChinaIntroductionOveractivation of the sympathetic nerve system can lead to a sustained increase in heart rate, which may impair blood perfusion and organ function. Previous studies have demonstrated that the use of β-blockers like esmolol can reduce heart rate, thereby improving clinical outcomes in patients with septic shock. For acute pancreatitis (AP), which shares a similar inflammatory pathophysiology with sepsis, previous experimental and observational studies showed significant sympathetic excitation during the acute phase, and the use of β-blockers might be clinically beneficial. This study aims to test the hypothesis that early intravenous esmolol administration to control heart rate will improve the incidence and duration of organ failure in patients with predicted severe acute pancreatitis (pSAP).MethodsThis is an investigator-initiated, multicenter, open-label, randomized controlled trial. All patients with pSAP who still exhibit elevated heart rate (≥110 bpm) after 6 h of adequate intravenous fluid resuscitation within the first 72 h of symptom onset will be screened for eligibility. A total of 146 participants will be randomized to receive either esmolol or standard care. Patients in the esmolol group will receive a continuous esmolol infusion to maintain a heart rate between 80 and 94 beats per minute (bpm) within the first 96 h of randomization. The primary endpoint is organ failure free and alive days (OFFDs) to day 14 after trial entry. Secondary endpoints are comprised of both process and clinical measures, including heart rate variability, the proportion of patients’ heart rate recovered to <95 bpm, changes in plasma interleukin-6 and C-reactive protein between day 1 and day 5, in hospital and 90-day mortality, new-onset organ failure, free and alive days to day 30 for intensive care admission, and requirement of mechanical ventilation, vasopressor use, and renal replacement therapy.DiscussionThis study will provide top-class evidence concerning the effects of heart rate control with a classic β-blocker on the incidence and duration of organ failure in patients with pSAP and increased heart rate.Ethics and disseminationThis study has been approved by the ethics committee of Jinling Hospital, Nanjing University (2022DZKY-076-02) and all participating sites. Results will be disseminated through peer-reviewed journals and scientific conferences.Trial registrationIdentifier, ChiCTR2400080160.https://www.frontiersin.org/articles/10.3389/fmed.2025.1642721/fullacute pancreatitisβ-blockersesmololheart rateorgan function |
| spellingShingle | Mingfeng Huang Rong Wei Lu Ke Weijian Li Jian Song Haibin Ni Xiaofei Huang Yun Sun Lu Fu Yanhua Li Dong Zhang Bin Han Jing Zhang Yingying Hu Chong Zhang Zhongyan Sheng Wenwen Feng Lin Gao Wenjian Mao Yuxiu Liu Yuxiu Liu Bo Ye Zhihui Tong Weiqin Li Efficacy and safety of heart rate control with esmolol on the incidence and duration of organ failure in predicted severe acute pancreatitis: protocol of a multicenter, open-label, randomized controlled trial Frontiers in Medicine acute pancreatitis β-blockers esmolol heart rate organ function |
| title | Efficacy and safety of heart rate control with esmolol on the incidence and duration of organ failure in predicted severe acute pancreatitis: protocol of a multicenter, open-label, randomized controlled trial |
| title_full | Efficacy and safety of heart rate control with esmolol on the incidence and duration of organ failure in predicted severe acute pancreatitis: protocol of a multicenter, open-label, randomized controlled trial |
| title_fullStr | Efficacy and safety of heart rate control with esmolol on the incidence and duration of organ failure in predicted severe acute pancreatitis: protocol of a multicenter, open-label, randomized controlled trial |
| title_full_unstemmed | Efficacy and safety of heart rate control with esmolol on the incidence and duration of organ failure in predicted severe acute pancreatitis: protocol of a multicenter, open-label, randomized controlled trial |
| title_short | Efficacy and safety of heart rate control with esmolol on the incidence and duration of organ failure in predicted severe acute pancreatitis: protocol of a multicenter, open-label, randomized controlled trial |
| title_sort | efficacy and safety of heart rate control with esmolol on the incidence and duration of organ failure in predicted severe acute pancreatitis protocol of a multicenter open label randomized controlled trial |
| topic | acute pancreatitis β-blockers esmolol heart rate organ function |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2025.1642721/full |
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