Lewis Sharon R, Butler Andrew R, Brammar Andrew, Nicholson Amanda, Smith Andrew F
Patient Safety Research, Royal Lancaster Infirmary, Pointer Court 1, Ashton Road, Lancaster, UK, LA1 1RP.
Cochrane Database Syst Rev. 2016 Mar 14;3(3):CD003004. doi: 10.1002/14651858.CD003004.pub4.
Proximal femoral fracture (PFF) is a common orthopaedic emergency that affects mainly elderly people at high risk of complications. Advanced methods for managing fluid therapy during treatment for PFF are available, but their role in reducing risk is unclear.
To compare the safety and effectiveness of the following methods of perioperative fluid optimization in adult participants undergoing surgical repair of hip fracture: advanced invasive haemodynamic monitoring, such as transoesophageal Doppler and pulse contour analysis; a protocol using standard measures, such as blood pressure, urine output and central venous pressure; and usual care.Comparisons of fluid types (e.g. crystalloid vs colloid) and other methods of optimizing oxygen delivery, such as blood product therapies and pharmacological treatment with inotropes and vasoactive drugs, are considered in other reviews.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 9); MEDLINE (October 2012 to September 2015); and EMBASE (October 2012 to September 2015) without language restrictions. We ran forward and backward citation searches on identified trials. We searched ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform for unpublished trials. This is an updated version of a review published originally in 2004 and updated first in 2013 and again in 2015. Original searches were performed in October 2003 and October 2012.
We included randomized controlled trials (RCTs) in adult participants undergoing surgical treatment for PFF that compared any two of advanced haemodynamic monitoring, protocols using standard measures or usual care, irrespective of blinding, language or publication status.
Two review authors assessed the impact of fluid optimization interventions on outcomes of mortality, length of hospital stay, time to medical fitness, whether participants were able to return to pre-fracture accommodation at six months, participant mobility at six months and adverse events in-hospital. We pooled data using risk ratio (RR) or mean difference (MD) for dichotomous or continuous data, respectively, on the basis of random-effects models.
We included in this updated review five RCTs with a total of 403 participants, and we added two new trials identified during the 2015 search. One of the included studies was found to have a high risk of bias; no trial featured all pre-specified outcomes. We found two trials for which data are awaited for classification and one ongoing trial.Three studies compared advanced haemodynamic monitoring with a protocol using standard measures; three compared advanced haemodynamic monitoring with usual care; and one compared a protocol using standard measures with usual care. Meta-analyses for the two advanced haemodynamic monitoring comparisons are consistent with both increased and decreased risk of mortality (RR Mantel-Haenszel (M-H) random-effects 0.41, 95% confidence interval (CI) 0.14 to 1.20; 280 participants; RR M-H random-effects 0.45, 95% CI 0.07 to 2.95; 213 participants, respectively). The study comparing a protocol with usual care found no difference between groups for this outcome.Three studies comparing advanced haemodynamic monitoring with usual care reported data for length of stay and time to medical fitness. There was no statistically significant difference between groups for these outcomes in the two studies that we were able to combine (MD IV fixed 0.63, 95% CI -1.70 to 2.96); MD IV fixed 0.01, 95% CI -1.74 to 1.71, respectively) and no statistically significant difference in the third study. One study reported reduced time to medical fitness when comparing advanced haemodynamic monitoring with a protocol, and when comparing protocol monitoring with usual care.The number of participants with one or more complications showed no statistically significant differences in each of the two advanced haemodynamic monitoring comparisons (RR M-H random-effects 0.83, 95% CI 0.59 to 1.17; 280 participants; RR M-H random-effects 0.72, 95% CI 0.40 to 1.31; 173 participants, respectively), nor any differences in the protocol and usual care comparison.Only one study reported the number of participants able to return to normal accommodation after discharge with no statistically significant difference between groups.There were few studies with a small number of participants, and by using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation Working Group) approach, we judged the quality of the outcome evidence as low. We had included one study with a high risk of bias, but upon applying GRADE, we downgraded the quality of this outcome evidence to very low.
AUTHORS' CONCLUSIONS: Five studies including a total of 403 participants provided no evidence that fluid optimization strategies improve outcomes for participants undergoing surgery for PFF. Further research powered to test some of these outcomes is ongoing.
股骨近端骨折(PFF)是一种常见的骨科急症,主要影响并发症风险较高的老年人。治疗PFF期间有先进的液体治疗管理方法,但它们在降低风险方面的作用尚不清楚。
比较以下围手术期液体优化方法在接受髋部骨折手术修复的成年参与者中的安全性和有效性:先进的有创血流动力学监测,如经食管多普勒和脉搏轮廓分析;使用标准测量方法(如血压、尿量和中心静脉压)的方案;以及常规护理。其他综述考虑了液体类型(如晶体液与胶体液)的比较以及其他优化氧输送的方法,如血液制品治疗和使用正性肌力药及血管活性药物的药物治疗。
我们检索了Cochrane对照试验中心注册库(CENTRAL;2015年第9期);MEDLINE(2012年10月至2015年9月);以及EMBASE(2012年10月至2015年9月),无语言限制。我们对已识别的试验进行了向前和向后的引文检索。我们在ClinicalTrials.gov和世界卫生组织(WHO)国际临床试验注册平台上搜索未发表的试验。这是对2004年首次发表、2013年首次更新并于2015年再次更新的综述的更新版本。最初的检索在2003年10月和2012年10月进行。
我们纳入了成年PFF手术治疗参与者的随机对照试验(RCT),这些试验比较了先进血流动力学监测、使用标准测量方法的方案或常规护理中的任意两种,无论是否采用盲法、语言或发表状态。
两位综述作者评估了液体优化干预对死亡率、住院时间、恢复医疗适宜性的时间、参与者在六个月时是否能够回到骨折前住所、参与者在六个月时的活动能力以及院内不良事件等结局的影响。我们分别基于随机效应模型,对二分类或连续数据使用风险比(RR)或平均差(MD)合并数据。
在本次更新综述中,我们纳入了五项RCT,共403名参与者,并增加了2015年检索期间识别出的两项新试验。其中一项纳入研究被发现存在高偏倚风险;没有试验涵盖所有预先指定的结局。我们发现有两项试验的数据有待分类,还有一项正在进行的试验。三项研究比较了先进血流动力学监测与使用标准测量方法的方案;三项比较了先进血流动力学监测与常规护理;一项比较了使用标准测量方法的方案与常规护理。两项先进血流动力学监测比较的Meta分析结果显示死亡率风险既可能增加也可能降低(RR Mantel-Haenszel(M-H)随机效应 0.41,95%置信区间(CI)0.14至1.20;280名参与者;RR M-H随机效应 0.45,95%CI 0.07至2.95;分别为213名参与者)。比较方案与常规护理的研究在该结局上未发现组间差异。三项比较先进血流动力学监测与常规护理的研究报告了住院时间和恢复医疗适宜性的时间数据。在我们能够合并的两项研究中,这些结局在组间无统计学显著差异(MD IV固定效应 0.63,95%CI -1.70至2.96);MD IV固定效应 0.01,95%CI -1.74至1.71,第三项研究也无统计学显著差异。一项研究报告在比较先进血流动力学监测与方案以及比较方案监测与常规护理时,恢复医疗适宜性的时间缩短。在两项先进血流动力学监测比较中,有一项或多项并发症的参与者数量在组间均无统计学显著差异(RR M-H随机效应 0.83,95%CI 0.59至1.17;280名参与者;RR M-H随机效应 0.72,95%CI 0.40至1.31;分别为173名参与者),方案与常规护理比较也无差异。只有一项研究报告了出院后能够回到正常住所的参与者数量,组间无统计学显著差异。研究数量少且参与者人数不多,通过使用GRADE(推荐分级、评估、制定与评价工作组)方法,我们将结局证据的质量判定为低。我们纳入了一项存在高偏倚风险的研究,但应用GRADE后,我们将该结局证据的质量降级为极低。
五项共纳入403名参与者的研究未提供证据表明液体优化策略能改善接受PFF手术的参与者的结局。正在进行进一步的研究以检验其中一些结局。