脓毒症和脓毒性休克中的液体治疗（FISSH）：一项初步随机对照试验方案
Fluids in Sepsis and Septic Shock (FISSH): protocol for a pilot randomised controlled trial.
作者信息
Rochwerg Bram, Millen Tina, Austin Peggy, Zeller Michelle, D'Aragon Frédérick, Jaeschke Roman, Masse Marie-Hélène, Mehta Sangeeta, Lamontagne Francois, Meade Maureen, Guyatt Gordon, Cook Deborah J
机构信息
Department of Medicine, Division of Critical Care, McMaster University, Hamilton, Ontario, Canada.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
出版信息
BMJ Open. 2017 Jul 20;7(7):e017602. doi: 10.1136/bmjopen-2017-017602.
INTRODUCTION
Observational evidence suggests physiological benefits and lower mortality with lower chloride solutions; however, 0.9% saline remains the most widely used fluid worldwide. Given uncertainty regarding the association of lower chloride on mortality, it is unlikely that practice will change without direct randomised clinical trial (RCT) evidence. This pilot RCT will investigate the feasibility of a large-scale trial directly comparing low chloride with high chloride fluids in patients with septic shock.
METHODS AND ANALYSIS
This is a randomised, concealed, blinded parallel-group multicentre pilot trial. We will include adult critically ill patients with septic shock, defined as ongoing hypotension despite 1 L of fluid, or a serum lactate >4 mmol/L, who are within 6 hours of hospital presentation or rapid response team activation. We will exclude patients if they have an aetiology of shock other than sepsis, if they have acute burn injury, elevated intracranial pressure, intent to withdraw life support or previous enrolment in this or a competing trial. Following informed consent, patients will be randomised to a low chloride fluid strategy or a high chloride fluid strategy for the duration of their ICU stay or until 30 days postrandomisation. Clinicians, patients, families and research staff will be blinded. The primary outcome for this trial will be feasibility, assessed by consent rate, recruitment success and protocol adherence. Patient-important clinical outcomes include mortality, receipt of renal replacement therapy, intensive care unit and hospital lengths of stay and surrogate outcomes of incidence of acidosis, hyperkalaemia and acute kidney injury.
ETHICS AND DISSEMINATION
This pilot trial will test the feasibility of conducting the main trial, which will examine the effect of high versus low chloride fluids in patients with septic shock on patient-important outcomes.
TRIAL REGISTRATION NUMBER
NCT02748382, registered 8 April 2016.
PROTOCOL DATE
1 July 2016.
引言
观察性证据表明，使用含氯量较低的溶液具有生理益处且死亡率较低；然而，0.9%的生理盐水仍是全球使用最广泛的液体。鉴于含氯量较低与死亡率之间的关联存在不确定性，若无直接的随机临床试验（RCT）证据，实践不太可能改变。这项先导性RCT将研究在感染性休克患者中直接比较低氯液体与高氯液体的大规模试验的可行性。
方法与分析
这是一项随机、隐蔽、盲法平行组多中心先导性试验。我们将纳入患有感染性休克的成年危重症患者，其定义为尽管输注了1升液体仍持续低血压，或血清乳酸>4 mmol/L，且在入院后6小时内或快速反应小组启动后。如果患者休克病因不是脓毒症、有急性烧伤、颅内压升高、有意撤销生命支持或之前已参加过本试验或其他竞争性试验，将被排除。在获得知情同意后，患者将被随机分配至低氯液体策略或高氯液体策略，直至其入住重症监护病房（ICU）结束或随机分组后30天。临床医生、患者、家属和研究人员将保持盲态。本试验的主要结局将是可行性，通过同意率、招募成功率和方案依从性进行评估。对患者重要的临床结局包括死亡率、接受肾脏替代治疗情况、ICU和住院时间，以及酸中毒、高钾血症和急性肾损伤发生率等替代结局。
伦理与传播
这项先导性试验将测试进行主要试验的可行性，主要试验将研究感染性休克患者中高氯液体与低氯液体对患者重要结局的影响。
试验注册号
NCT02748382，于2016年4月8日注册。
方案日期
2016年7月1日。
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