Bradford Natalie K, Edwards Rachel M, Chan Raymond J
Centre for Children's Health Research, Institute of Health and Biomedical Innovation, Queensland University of Technology (QUT), South Brisbane, Australia.
Oncology Services Group, Queensland Children's Hospital, South Brisbane, Australia.
Cochrane Database Syst Rev. 2020 Apr 30;4(4):CD010996. doi: 10.1002/14651858.CD010996.pub3.
Guidelines and clinical practice for the prevention of complications associated with central venous catheters (CVC) around the world vary greatly. Most institutions recommend the use of heparin to prevent occlusion; there is debate, however, regarding the need for heparin and evidence to suggest normal saline (0.9% sodium chloride) may be as effective. The use of heparin is not without risk, may be unnecessary and is also associated with increased cost. This is an update of the review published in 2015.
To assess the clinical effects (benefits and harms) of intermittent flushing of normal saline versus heparin to prevent occlusion in long-term central venous catheters in infants and children.
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases; World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 9 April 2019. We also undertook reference checking, citation searching and contact with study authors to identify additional studies.
We included randomised controlled trials (RCTs) that compared the efficacy of intermittent flushing with normal saline versus heparin to prevent occlusion of long-term CVCs in infants and children aged up to 18 years of age. We excluded temporary CVCs and peripherally inserted central catheters (PICC).
Two review authors independently assessed trial inclusion criteria, trial quality and extracted data. We assessed study quality with the Cochrane 'Risk of bias' tool. For dichotomous outcomes, we calculated the rate ratio (RR) and corresponding 95% confidence interval (CI). We pooled data using a random-effects model; and we used GRADE to assess the overall certainty of the evidence supporting the outcomes assessed in this review.
We identified one new study for this update, bringing the total number of included studies to four (255 participants). The four trials directly compared the use of normal saline and heparin; the studies all used different protocols for the intervention and control arms, however, and all used different concentrations of heparin. Different frequencies of flushes were also reported between studies. In addition, not all studies reported on all outcomes. The certainty of the evidence ranged from moderate to very low because there was no blinding; heterogeneity and inconsistency between studies was high; and the CIs were wide. CVC occlusion was assessed in all four trials. We were able to pool the results of two trials for the outcomes of CVC occlusion and CVC-associated blood stream infection. The estimated RR for CVC occlusion per 1000 catheter days between the normal saline and heparin groups was 0.75 (95% CI 0.10 to 5.51; 2 studies, 229 participants; very low certainty evidence). The estimated RR for CVC-associated blood stream infection was 1.48 (95% CI 0.24 to 9.37; 2 studies, 231 participants; low-certainty evidence). The duration of catheter placement was reported to be similar for the two study arms in one study (203 participants; moderate-certainty evidence), and not reported in the remaining studies.
AUTHORS' CONCLUSIONS: The review found that there was not enough evidence to determine the effects of intermittent flushing with normal saline versus heparin to prevent occlusion in long-term central venous catheters in infants and children. It remains unclear whether heparin is necessary to prevent occlusion, CVC-associated blood stream infection or effects duration of catheter placement. Lack of agreement between institutions around the world regarding the appropriate care and maintenance of these devices remains.
世界各地预防中心静脉导管(CVC)相关并发症的指南和临床实践差异很大。大多数机构建议使用肝素预防导管堵塞;然而,对于是否需要肝素存在争议,且有证据表明生理盐水(0.9%氯化钠)可能同样有效。使用肝素并非没有风险,可能不必要,而且还会增加成本。这是对2015年发表的综述的更新。
评估间歇性冲洗生理盐水与肝素预防婴幼儿长期中心静脉导管堵塞的临床效果(益处和危害)。
Cochrane血管信息专家检索了Cochrane血管专业注册库、CENTRAL、MEDLINE、Embase和CINAHL数据库;检索了世界卫生组织国际临床试验注册平台和ClinicalTrials.gov试验注册库至2019年4月9日的数据。我们还进行了参考文献核对、引文检索并与研究作者联系以识别其他研究。
我们纳入了比较间歇性冲洗生理盐水与肝素预防18岁及以下婴幼儿长期CVC堵塞疗效的随机对照试验(RCT)。我们排除了临时CVC和外周静脉穿刺中心静脉导管(PICC)。
两位综述作者独立评估试验纳入标准、试验质量并提取数据。我们使用Cochrane“偏倚风险”工具评估研究质量。对于二分法结局,我们计算了率比(RR)和相应的95%置信区间(CI)。我们使用随机效应模型汇总数据;并使用GRADE评估支持本综述中评估结局的证据的总体确定性。
我们为本次更新确定了一项新研究,使纳入研究总数达到四项(255名参与者)。四项试验直接比较了生理盐水和肝素的使用;然而,这些研究在干预组和对照组均采用了不同方案,且均使用了不同浓度的肝素。研究之间还报告了不同的冲洗频率。此外,并非所有研究都报告了所有结局。证据的确定性从中度到极低,因为没有采用盲法;研究之间的异质性和不一致性很高;且置信区间很宽。所有四项试验均评估了CVC堵塞情况。我们能够汇总两项试验关于CVC堵塞和CVC相关血流感染结局的结果。生理盐水组和肝素组每1000导管日CVC堵塞的估计RR为0.75(95%CI 0.10至5.51;2项研究,229名参与者;极低确定性证据)。CVC相关血流感染的估计RR为1.48(95%CI 0.24至9.37;2项研究,231名参与者;低确定性证据)。一项研究报告两个研究组的导管留置时间相似(203名参与者;中度确定性证据),其余研究未报告。
该综述发现,没有足够证据确定间歇性冲洗生理盐水与肝素预防婴幼儿长期中心静脉导管堵塞的效果。肝素对于预防堵塞、CVC相关血流感染或对导管留置时间的影响是否必要仍不清楚。世界各地机构在这些装置的适当护理和维护方面仍未达成一致。