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    • A Randomized Open Label, Parallel-Group Study to Evaluate the Hemodynamic Effects of Cafedrine/Theodrenaline Vs Noradrenaline in the Treatment of Intraoperative Hypotension after Induction of General Anesthesia: the "HERO" Study Design and Rationale.

    Benjamin Vojnar,Goetz Geldner,Susanne Huljic-Lankinen,Melanie Murst,Thomas Keller,Stephan Weber,Christine Gaik,Tilo Koch,Andreas Weyland,Peter Kranke,Sascha Kreuer,Daniel Chappell,Leopold Eberhart

    CURRENT MEDICAL RESEARCH AND OPINION（2023）

    Philipps Univ Marburg | Hosp Ludwigsburg | Ratiopharm GmbH | Teva GmbH | ACOMED Stat | Carl von Ossietzky Univ Oldenburg | Univ Hosp Wurzburg | Saarland Univ | Varisano Hosp Frankfurt Hochst | Univ Marburg

    Cited 1|Views15
    Abstract
    Abstract Objective Intraoperative arterial hypotension (IOH) is associated with poor patient outcome. This study aims to compare the hemodynamic effects of Cafedrine/Theodrenaline (C/T) and Noradrenaline (NA) for the treatment of hypotension in patients who develop IOH after anesthesia induction. Research design and methods This is a national, randomized, parallel-group, multicenter, and open-label study. Adult patients (≥50 years, ASA-classification III–IV) who undergo elective surgery will be included. When IOH (MAP <70 mmHg) develops, C/T or NA will be given as a bolus injection (“bolus phase”, 0–20 min after initial application) and subsequently as continuous infusion (“infusion phase”, 21–40 min after initial application) to achieve MAP = 90 mmHg. Hemodynamic data are captured in real time by advanced hemodynamic monitoring. Results Primary endpoints, i.e. the treatment-related difference in average mean arterial pressure (MAP) during the “infusion phase” and the treatment-related difference in average cardiac index during the “bolus phase” are assessed (fixed-sequence method). Non-inferiority of C/T compared to NA in achieving 90 mmHg (MAP) when applied as continuous infusion is hypothesized. In addition, superiority of C/T over NA, applied as bolus injection, in increasing cardiac index is postulated. It is estimated that 172 patients are required to establish statistical significance with a power of 90%. After adjusting for ineligibility and dropout rate, 220 patients will be screened. Conclusion This clinical trial will yield evidence for marketing authorization of C/T applied as continuous infusion. Additionally, the effects of C/T compared to NA on cardiac index will be assessed. First results of the “HERO”-study are expected in 2024. DRKS identifier: DRKS00028589. EudraCT identifier: 2021-001954-76.
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    Key words
    Intraoperative hypotension,cafedrine,theodrenaline,akrinor,noradrenaline,hemodynamic monitoring,clinical trial
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    【要点】：本研究设计了一项全国性的随机平行组、多中心、开放标签的临床试验，旨在比较Cafedrine/Theodrenaline（C/T）和去甲肾上腺素（NA）在治疗麻醉诱导后出现的低血压时的血流动力学效应，其结果预期将为C/T的连续输注方式提供市场授权证据，并评估C/T与NA对心指数的影响。
    

    【方法】：采用先进的心动力学监测实时捕捉血流动力学数据，对接受择期手术的成年患者（年龄大于等于50岁，ASA分类III-IV级）在出现低血压（MAP小于70 mmHg）时，给予C/T或NA的 bolus 注射和连续输注，以达到MAP=90 mmHg。
    

    【实验】：研究的主要终点是在“输注阶段”的平均平均动脉压（MAP）的治疗相关差异以及在“bolus阶段”的平均心指数的治疗相关差异。预期C/T与NA在连续输注时达到90 mmHg（MAP）的非劣效性，同时假设C/T在bolus注射时相比NA有优越性。预计需要172名患者以90%的统计力证明统计显著性，考虑到不适宜资格和退出的比率，将筛选220名患者。预期在2024年获取“HERO”研究的初步结果。DRKS标识符：DRKS00028589。EudraCT标识符：2021-001954-76。