Managing traumatic brain injury (TBI) patients with a cerebral perfusion pressure (CPP) near to the cerebral autoregulation (CA)-guided “optimal” CPP (CPPopt) value is associated with improved outcome and might be useful to individualize care, but has never been prospectively evaluated. This study evaluated the feasibility and safety of CA-guided CPP management in TBI patients requiring intracranial pressure monitoring and therapy (TBIicp patients). The CPPopt Guided Therapy: Assessment of Target Effectiveness (COGiTATE) parallel two-arm feasibility trial took place in four tertiary centers. TBIicp patients were randomized to either the Brain Trauma Foundation (BTF) guideline CPP target range (control group) or to the individualized CA-guided CPP targets (intervention group). CPP targets were guided by six times daily software-based alerts for up to 5 days. The primary feasibility end-point was the percentage of time with CPP concordant (±5 mm Hg) with the set CPP targets. The main secondary safety end-point was an increase in therapeutic intensity level (TIL) between the control and intervention group. Twenty-eight patients were randomized to the control and 32 patients to the intervention group. CPP in the intervention group was in the target range for 46.5% (interquartile range, 41.2–58) of the monitored time, significantly higher than the feasibility target specified in the published protocol (36%; p < 0.001). There were no significant differences between groups for TIL or for other safety end-points. Conclusively, targeting an individual and dynamic CA-guided CPP is feasible and safe in TBIicp patients. This encourages a prospective trial powered for clinical outcomes.

中文翻译：

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创伤性脑损伤后以自动调节引导的脑灌注压为目标 (COGiTATE)：一项可行性随机对照临床试验


管理脑灌注压 (CPP) 接近脑自动调节 (CA) 指导的“最佳”CPP (CPPopt) 值的创伤性脑损伤 (TBI) 患者与改善预后相关，可能有助于个体化护理，但从未有过这种情况。进行了前瞻性评估。本研究评估了需要颅内压监测和治疗的 TBI 患者（TBIicp 患者）中 CA 引导的 CPP 管理的可行性和安全性。 CPPopt 引导治疗：目标有效性评估 (COGiTATE) 并行双臂可行性试验在四个三级中心进行。 TBIicp 患者被随机分配至脑创伤基金会 (BTF) 指南 CPP 目标范围（对照组）或个体化 CA 指导的 CPP 目标（干预组）。 CPP 目标由每天六次基于软件的警报引导，持续时间长达 5 天。主要可行性终点是 CPP 与设定的 CPP 目标一致（±5 mm Hg）的时间百分比。主要的次要安全终点是对照组和干预组之间治疗强度水平（TIL）的增加。 28 名患者被随机分配到对照组，32 名患者被分配到干预组。干预组中的 CPP 在监测时间的 46.5%（四分位距，41.2-58）内处于目标范围内，显着高于已发布方案中指定的可行性目标（36%； p < 0.001）。各组之间的 TIL 或其他安全终点没有显着差异。总之，针对 TBIicp 患者，针对个体和动态 CA 引导的 CPP 是可行且安全的。这鼓励了为临床结果提供动力的前瞻性试验。