The cardiac output optimisation following liver transplant (COLT) trial: a feasibility randomised controlled trial.,HPB

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The cardiac output optimisation following liver transplant (COLT) trial: a feasibility randomised controlled trial.
HPB ( IF 2.7 ) Pub Date : 2019-12-23 , DOI: 10.1016/j.hpb.2019.11.011
Daniel Martin ₁ , Rahul Koti ₂ , Kurinchi Gurusamy ₃ , Louise Longworth ₄ , Jeshika Singh ₅ , Farid Froghi ₂ , Fiammetta Soggiu ₂ , Susan Mallett ₆ , Nick Schofield ₆ , Linda Selves ₇ , Douglas Thorburn ₇ , Christine Eastgate ₆ , Helder Filipe ₆ , Margaret McNeil ₆ , Zacharias Anastasiou ₈ , Brian Davidson ₂ ,

Affiliation

University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.
University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.
University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.
PHMR Limited, Berkeley Works, Berkley Grove, London, NW1 8XY, UK.
PHMR Limited, Berkeley Works, Berkley Grove, London, NW1 8XY, UK; Health Economics Research Group, Brunel University, Uxbridge, UB8 3PH, UK.
Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.
Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.
Department of Statistical Science, University College London, Gower St, London, WC1E 6BT, UK.

Background

Perioperative goal directed fluid therapy (GDFT) has been shown to reduce postoperative complications following major surgery; this intervention has not been formally evaluated in the setting of liver transplantation.

Methods

We conducted a prospective trial of GDFT following liver transplantation randomising patients with liver cirrhosis to either 12 h of GDFT using non-invasive cardiac output monitoring or standard care (SC). The primary outcome was feasibility. Secondary outcomes included survival, postoperative complications (Clavien-Dindo), quality of life (by EQ-5D-5L) and resource use. Trial specific follow up occurred at 90 and 180 days after surgery.

Results

The study was feasible. Of 224 eligible patients, 122 were approached, 114 consented to participate and 60 were enrolled into the trial. The mean (SD) volume of IV crystalloid administered to the GDFT group during the 12-h study period was 3968 (2073) ml for the GDFT group and 2510 (1026) ml for the SC group. As regards secondary outcomes there was no difference in survival or overall complication rates. There was no significant difference in quality of life scores and resource use between the groups.

Conclusion

A randomised study of GDFT following liver transplantation is feasible. A post-trial stakeholder meeting supported proceeding with a full multi-centre trial.

中文翻译：

肝移植 (COLT) 试验后的心输出量优化：一项可行性随机对照试验。

背景

围手术期目标导向液体治疗 (GDFT) 已被证明可减少大手术后的术后并发症；这种干预尚未在肝移植环境中进行正式评估。

方法

我们在肝移植后进行了一项 GDFT 的前瞻性试验，将肝硬化患者随机分配到 GDFT 的 12 小时，使用无创心输出量监测或标准护理 (SC)。主要结果是可行性。次要结果包括生存率、术后并发症（Clavien-Dindo）、生活质量（通过 EQ-5D-5L）和资源使用。试验具体随访发生在手术后 90 天和 180 天。

结果

该研究是可行的。在 224 名符合条件的患者中，有 122 名被联系，114 名同意参与，60 名被纳入试验。在 12 小时研究期间，给予 GDFT 组的 IV 晶体液的平均 (SD) 体积为 GDFT 组的 3968 (2073) ml 和 SC 组的 2510 (1026) ml。至于次要结局，生存率或总体并发症发生率没有差异。各组之间的生活质量评分和资源使用没有显着差异。