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Hypertonic saline in the traumatic hypovolemic shock: meta-analysis Jia-Wei Wang, MD, PhD, Jin-Ping Li, MD, PhD, Ying-lun Song, MD, Ke Tan, MD, PhD, Yu Wang, MD, Tao Li, MD, Peng Guo, MD, Xiong Li, MD, PhD, Yan Wang, MD, and Qi-Huang Zhao, MD, PhD* Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, P.R. China

article info

abstract

Article history:

Background: A wealth of evidence from animal experiments has indicated that hypertonic

Received 13 December 2013

saline (HS) maybe a better choice for fluid resuscitation in traumatic hypovolemic shock in

Received in revised form

comparison with conventional isotonic saline. However, the results of several clinical trials

16 March 2014

raised controversies on the superiority of fluid resuscitation with HS. This meta-analysis

Accepted 15 April 2014

was performed to better understand the efficacy of HS in patients with traumatic hypo-

Available online xxx

volemic shock comparing with isotonic saline. Materials and methods: According to the search strategy, we searched the PubMed, EMBASE,

Keywords:

and the Cochrane Central Register of Controlled Trials, which was completed on October

Hypertonic saline

2013. After literature searching, two investigators independently performed the literature

Traumatic hypovolemic shock

screening, assessment of quality of the included trials, and data extraction. Disagreements

Meta-analysis

were resolved by consensus or by a third investigator if needed. The outcomes included

Randomized controlled trial

mortality, blood pressure, fluid requirement, and serum sodium. Results: Six randomized controlled trials were included in the meta-analysis. The pooled risk ratio for mortality at discharge was 0.96 (95% confidence interval [CI], 0.82e1.14), whereas the pooled mean difference for the change in systolic blood pressure from baseline and the level of serum sodium after infusion was 6.47 (95% CI, 1.31e11.63) and 7.94 (95% CI, 7.38e8.51), respectively. Current data were insufficient to evaluate the effect of HS on the fluid requirement for the resuscitation. Conclusions: The present meta-analysis was unable to demonstrate a clinically important improvement in mortality after the HS administration. Moreover, we observed HS administration maybe accompanied with significant increase in blood pressure and serum sodium. ª 2014 Elsevier Inc. All rights reserved.

1.

Introduction

As a leading cause of death and morbidity worldwide, hypovolemic shock resulting from traumatic injury has received considerable attention in the clinical practice [1]. Unfortunately, although the deleterious effects of traumatic

hypovolemic shock have long been recognized and intensive researches have been carried out in the area, the strategies of fluid resuscitation in the patients with traumatic hypovolemic shock remain controversial [2]. It is well known that conventional fluid resuscitation protocols posit an important role of isotonic saline such as

* Corresponding author. Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, 8 South Gongti Road, Beijing 100020, P.R. China. Tel.: þ86 10 85231761; fax: þ86 10 85231761. E-mail address: [email protected] (Q.-H. Zhao). 0022-4804/$ e see front matter ª 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jss.2014.04.027

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normal saline and lactated ringers in the treatment of patients with traumatic hypovolemic shock [3]. According to the Advanced Trauma Life Support guidelines, aggressive fluid resuscitation with up to two or more liters of isotonic saline is suggested [4]. However, the side effects of large-volume isotonic saline are also concerned. Since the intravascular fluid can leak into the interstitial space because of the increased capillary permeability in the setting of trauma, large-volume resuscitation may cause “water-logging” effects and cell swelling, which can result in organ dysfunction and ultimate death [5]. Furthermore, it is reported that the administration of large-volume isotonic saline is associated with significantly increased inflammatory response [6], whereas the latter also can exaggerate the “water-logging” effects. These issues have led to increasing enthusiasm about the development of alternative approaches in fluid resuscitation [7]. In recent years, hypertonic saline (HS) has emerged as an attractive alternative in fluid management in a variety of clinical practices including traumatic hypovolemic shock [8]. A wealth of evidence from animal experiments has indicated that treatment with small volume of HS is able to effectively restore the hemodynamic stability and decrease the mortality in the models of traumatic hypovolemic shock [9]. The protective mechanism of HS may mainly involve its ability to shift fluid from interstitial and intracellular space to intravascular space by establishing the osmotic gradient across the vessel and cell [10]. Moreover, HS can modulate the overwhelming inflammatory response after trauma, which contributes to disturb the vicious inflammation cascades [11]. Previous several clinical trials have also shown that small-volume resuscitation with HS maybe superior to conventional fluid resuscitation with isotonic saline [8,9]. However, the impact of these trials on clinical practices has been limited because of various reasons such as small sample size and different research endpoints. Therefore, to better understand the efficacy of HS in patients with traumatic hypovolemic shock, we performed this meta-analysis of randomized controlled trials (RCTs) in the area.

2.

Materials and methods

2.1.

Study identification

We performed a systematic review of the published literature to identify all randomized controlled clinical trials in which HS has been used for the treatment of patients with traumatic hypovolemic shock in comparison with isotonic saline. Studies that were either not RCTs or that did not directly involve the effects of HS on the treatment of patients with traumatic hypovolemic shock were eliminated.

2.2.

Search strategy

Based on the text words or MeSH terms such as “saline solution, hypertonic,” “hypertonic saline,” “wounds and injuries,” “trauma,” “hypovolemia,” and “shock,” an electronic search for relevant articles was conducted on PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL)

without language limitation. We also complemented this by using the Related Articles function on PubMed and searching the reference lists of relevant articles. For full details of the search strategy, see Supplementary Data File 1. The search was performed independently by two investigators and was completed on October 2013.

2.3.

Literature screening

After literature search, two investigators independently reviewed the titles and abstracts of all studies identified and excluded those that were obviously irrelevant. The trials that totally did not involve the clinical practice of HS alone were excluded in the final analysis. The full articles of the remaining studies were then retrieved and independently reviewed by them using a structured form to determine eligibility and extract data. When the trials included multiple arms of patients with the treatment of HS alone or HS with colloids, the data from the patients with the treatment of HS alone without colloids were extracted. Disagreements were resolved by consensus or by a third investigator if needed. We contacted study authors for clarifications and further information as necessary.

2.4.

Quality assessment

The quality of eligible studies was formally evaluated by using the Cochrane Collaboration’s tool for assessing the risk of bias in RCTs. Specifically, studies were judged on (1) the adequacy of the random sequence generation, allocation concealment, and blinding; (2) the completeness of outcome data; (3) the possibility of selective outcome reporting; and (4) the existence of other potential sources of bias.

2.5.

Data extraction

We extracted the following data from each study: its design, objective, number of patients, method of delivery, timing of measurements, main results of the study, and follow-up results. The primary outcome assessed was mortality at discharge. The secondary outcomes included changes of the systolic blood pressure after the HS administration from baseline, fluid requirements in the research period scheduled for each trial, and the level of serum sodium after the administration of HS.

2.6.

Statistical analysis

A homogeneity-based method of meta-analysis was performed using Review Manager for Windows(version 5.2, The Cochrane Collaboration and Update Software) for prospective RCTs. Homogeneity between studies was assessed by means of standard Cochran Q and I2 statistics. Homogeneity was prespecified as P > 0.10 or I2 < 50%. A fixed-effect model was used to merge the values of relative risk and mean difference and to estimate the overall effect size when the homogeneity between studies was reached. Otherwise, a random-effect model was used in the statistics. Overall effect, risk ratio, mean difference, and 95% confidence interval (CI) were presented in the present systematic review.

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Table e The baseline characteristics of the six included trials. Study and year

Vassar 1990 [17] Younes 1992 [16] Vassar 1993a [15] Vassar 1993b [14] Cooper 2004 [13] Bulger 2011 [12]

Groups

Experimental Control Experimental Control Experimental Control Experimental Control Experimental Control Experimental Control

Study characteristics Number of patients

Age (y, mean)

Study fluid (250 mL)

Treating place

Outcome measures

32 27 35 35 85 84 50 45 114 115 256 376

32 38 31 31 32 31 31 37 38 37 36.8 36.2

HS LR HS NS HS NS HS LR HS LR HS NS

ER

Mortality, SBP, serum sodium

ER PH

Mortality, MAP, serum sodium, fluid requirement Mortality, SBP, serum sodium

PH

Mortality, SBP, serum sodium

PH

Mortality, SBP, serum sodium

PH

Mortality, SBP, serum sodium, fluid requirement

ER ¼ emergency room; LR ¼ lactated ringers; MAP ¼ mean arterial pressure; NS ¼ normal saline; PH ¼ prehospital; SBP ¼ systolic blood pressure.

3.2.

3.

Results

3.1.

Characteristics of included studies

In total, 66 articles were initially identified, of which 60 articles were excluded, leaving six studies for final analysis. Figure 1 described the flow diagram of search results and study selection. All the six included studies were prospective RCTs [12e17]. A total of 1254 participants were enrolled in the six trials, among which 567 patients (45.2%) were included in the group with HS treatment. The average age of participants in the included studies ranged from 31e38 y. All the included trials had distinct inclusion and exclusion criteria. Each trial described the baseline characteristics of the enrolled participants, and there were no significant differences in the baseline characteristics of participants between groups in these trials. Table summarized the baseline data of the six included trials. The concentration and volume of HS used in the six included trials was 7.5% and 250 mL, whereas the control groups were treated with 250 mL of normal saline in the three trials [12,15,16] or 250 mL of lactated Ringer solution in the three trials [13,14,17].

Risk of bias in included studies

Each trial reported that the study fluid was provided in the identical containers, and all the investigators were blinded to the treatment assignment. Five trials [12e15,17] had adequate description of allocation concealment while the allocation concealment is unclear in one trial [16]. There was no loss to follow-up in four trials [14e17]and the other two trials reported loss to follow-up [12,13]. The intentionto-treat analysis was used to treat the missing data in the two trials with a total of five participants lost to follow-up [12,13].

3.3.

Effect of HS on the mortality at discharge

As shown in Figure 2, each included trial reported the effect of HS on the mortality at discharge in patients with traumatic hypovolemic shock. The pooled risk ratio of mortality at discharge using HS compared with isotonic saline was 0.96 (95% CI, 0.82e1.14, P ¼ 0.66), indicating that there was no significant difference in mortality between the groups treated with either hypertonic or isotonic saline.

Fig. 1 e Flow chart of study inclusion in the present meta-analysis.

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Fig. 2 e Forest plot comparing the mortality at hospital discharge between the groups treated with either HS or isotonic saline. M-H [ ManteleHaenszel. (For interpretation of the references to color in this figure, the reader is referred to the web version of this article).

3.4.

Effect of HS on the change in systolic blood pressure

In the six included studies, five trials investigated the systolic blood pressure [12e15,17], whereas one trial studied the mean arterial pressure [16] before and after the administration of either hypertonic or isotonic saline. Furthermore, the change from baseline in systolic blood pressure was recorded directly in two studies [14,15]. The additional three studies [12,13,17] recorded the systolic blood pressure before and after the treatment of study fluid, in which the data presented in the primary studies were translated into change from baseline in the final meta-analysis according to the Cochrane Handbook for Systematic Reviews of Interventions. As indicated in Figure 3, the pooled mean difference of change in systolic blood pressure using HS compared with isotonic saline in five included studies was 6.47 (95% CI, 1.31e11.63, P ¼ 0.01), which suggested that HS could significantly increase the systolic blood pressure in patients with traumatic hypovolemic shock. After the exclusion of the three studies with translating data [12,13,17], the sensitivity analysis was done, which indicated the increase in systolic blood pressure by the treatment of HS remained significant (mean difference: 11.62, 95% CI, 1.32e21.92, P ¼ 0.03). In addition, mean arterial pressure in the study conducted by Younes et al. [16] showed significant increase in HS-treated patients comparing with the one treated with normal saline (P < 0.01).

3.5.

Effect of HS on the fluid requirement

There were two trials reported fluid requirement in the six included studies. Considering the clinical heterogeneity of different research protocols, the two studies were just described as followed. In a prospective double-blind study, Younes et al. [16] studied the effect of 250 mL of HS treatment on the fluid requirement to maintain systolic blood pressure reached 100 mm Hg in patients with severe hypovolemia. They found that significantly less volume of fluids were required to restore systolic pressure in the group treated with HS than the one given isotonic saline during the resuscitation process (median: 1000 mL versus 2000 mL, P < 0.01), which suggested fluid resuscitation with HS was beneficial in reducing the fluid requirement in shock. In another RCT conducted by Bulger et al. [12], the researchers investigated the effects of HS in patients after the severe injury with hemorrhagic shock. Initial resuscitation with 250 mL of HS was followed with additional fluids guided by local emergency medical services protocols. They found that the total fluids requirement during the first 24 h in the group treated with HS was similar to the one with isotonic saline treatment (11.6  10.4 versus 12.3  12.1 L, P > 0.05).

3.6.

Effect of HS on the serum sodium after infusion

Each included trial investigated the serum sodium after the infusion of HS in patients with traumatic hypovolemic shock,

Fig. 3 e Forest plot comparing the change in systolic blood pressure after the infusion of study fluid from baseline between the groups treated with either HS or isotonic saline. IV [ inverse variance. (For interpretation of the references to color in this figure, the reader is referred to the web version of this article).

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Fig. 4 e Forest plot comparing the level of serum sodium after the infusion of study fluid at emergence admission between the groups treated with either HS or isotonic saline. IV [ inverse variance. (For interpretation of the references to color in this figure, the reader is referred to the web version of this article).

among which four studies [12e15] reported the level of serum sodium after infusion of HS when arriving at emergency department. As shown in Figure 4, the pooled mean difference of serum sodium at arrival in emergency department in the four trials using HS compared with isotonic saline was 7.94 (95% CI, 7.38e8.51, P < 0.00001), indicating that infusion of HS could significantly increase the serum sodium. In the study conducted by Younes et al. [16], they found that the serum sodium in the group with HS treatment was significantly increased at 15 min after infusion (158  17.7 versus 143  23.7, P < 0.01) and retuned to pretreatment levels 30 min later (146  17.7 versus 141  29.6, P > 0.05) compared with the one in the group treated with isotonic saline. However, Vassar et al. [17] found that there was no significant difference in serum sodium at 4, 8, and 24 h after infusion of study fluid between the groups treated with either HS or isotonic saline (P > 0.05).

4.

Discussion

In the present meta-analysis of six randomized controlled clinical trials, we investigated the effects of HS administration on the mortality, blood pressure response, fluid requirement, and serum sodium in patients with traumatic hypovolemic shock. The main findings are as follows: (1) there was no significant difference in mortality at discharge in the group with HS treatment comparing with the one treated with isotonic saline; (2) HS was more effective than isotonic saline in the blood pressure restoration; (3) current data were insufficient to evaluate whether HS can reduce the fluid requirement in the resuscitation process; and (4) compared with isotonic saline treatment, HS administration may tend to significantly increase the level of serum sodium early after infusion. In the present meta-analysis, trials from before 2000 and trials from 2000 and after were combined for two reasons despite that there was improvement in the treatment of traumatic hypovolemic shock around about the year of 2000. On the one hand, considering that the patients in the subgroups in each trial included in the present meta-analysis were subjected to the same management criteria except for the study fluid; the effects of the variance within the treatment of traumatic hypovolemic shock that might affect the outcome were probably randomly allocated to the subgroups. On the other hand, all the therapeutic strategies in each trial

were performed according to the protocols on fluid resuscitation issued at the corresponding years, which would contribute to minimize the effects of confounding parameters in administration. In addition, as we all know, the prehospital interventions and emergency department care are the two main important aspects involved in the management and treatment of traumatic hypovolemic shock [3]. Mortality at discharge was selected as the primary outcome in the present meta-analysis, whereas HS used either out-of-hospital or in emergency room are considered to have potential effects on the mortality at discharge. Thus, it maybe appropriate to combine trials that administered the resuscitation fluid prehospital or on hospital arrival. In recent years, great interest has been focused on searching an ideal solution for the fluid resuscitation in patients with traumatic hypovolemic shock [8,9]. Because a series of animal experiments supported that the use of HS was beneficial in improving outcomes in animals with shock states, HS was widely used in clinic and considered as an alternative choice for the conventional isotonic fluid. However, our meta-analysis failed to show that HS could significantly improve mortality at discharge in patients with traumatic hypovolemic shock compared with isotonic saline. The possibility that we did not detect significant difference may result from the following causes. On the one hand, all the six included studies in the present meta-analysis, especially the early clinical trials [14e17], are limited by sample size and statistical power. As describe in Table, the largest trial included in our meta-analysis was the research conducted by Bulger et al. in 2011 [12], of which the number of final enrolled patients were only 23% of the proposed sample size because of the early stopping of the trial. On the other hand, in this metaanalysis, the mortality in groups was mainly investigated at hospital discharge in the included trials. Only one in six studies reported the survival rate at 6 months after trauma [13]. Previous studies have indicated that follow-up up to 12 mo or even longer seem to be appropriate to precisely evaluate the outcome in patients with trauma [18,19]. The short period of follow-up maybe not enough to assess the long-term effect of HS administration. Despite no significant difference in mortality found in both groups, present meta-analysis has demonstrated that HS treatment contributed to significant increase in blood pressure in the group compared with the one with isotonic saline. Rapid restoration of circulating volume in shock states has

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been shown theoretically to improve survival. Nevertheless, we recognize that the increase of blood pressure is merely a practical goal but maybe a moot point if not accompanied by improved patient functional outcomes. Furthermore, successful resuscitation from shock states does not guarantee an improved outcome as demonstrated in our meta-analysis and various previous studies. Notwithstanding this crucial limitation, we believe that data on the effective restoration of hypotension are valuable to practicing clinicians in the daily management of patients with traumatic hypovolemic shock, as blood pressure is undoubtedly included in the goal-directed therapy guideline for the fluid resuscitation in patients with shock [20,21]. As we all know, the fluid overload accompanied with fluid resuscitation in patients with shock is a critical issue deserving attention because it can lead to vicious consequences such as cell swelling and organ dysfunction. Thus, fluid requirement is chosen as the secondary outcome in the present meta-analysis. In the six included studies, only one study clearly reported that the fluids were administered according to the blood pressure goal, and its results indicated that HS could significantly reduce the total volume of fluid required for resuscitation in patients with shock in comparison with the isotonic solution [16]. The other studies just described additional fluid followed by the initial study fluid such as HS was given as guided by local protocols, which reported no significant difference in the total fluid requirement during the first 24 h after injury between the HS group and the isotonic saline group [12]. Therefore, although numerous animal experiments have already confirmed the effect of small-volume resuscitation arising from HS administration [22,23], current clinical data are insufficient to evaluate whether HS can reduce the fluid requirement in the resuscitation process. It is also important to consider any direct negative effects such as hypernatremia associated with the administration of HS. In the present meta-analysis, the effect of HS on serum sodium was also studied. Our study indicated that the administration of HS may tend to increase the level of serum sodium early after infusion, which is consistent with previous researches [8]. A wealth of previous data has suggested the hypernatremia after the infusion of HS is transient and will not last beyond 24 h, especially after single dose of infusion. Furthermore, a recent review has confirmed that the transient hypernatremia after doses administered in the study does not have any adverse consequences [24]. In addition, we should note that the study performed by Bulger et al. [12] was stopped early for futility and potential safety concern and post hoc analysis showed that there was an increase in mortality among those patients who did not receive any blood transfusion. The authors considered that mortality was higher in the group not receiving blood transfusion because of a shift toward earlier mortality in the hypertonictreated arms such that some patients died before blood transfusions were available or administered [12]. To date, no neurologic deficits or central pontine myelinolysis that may occur theoretically during the infusion of HS has been reported in any patient [8,9,17]. More studies in the future maybe beneficial to understand the potential side effects of HS treatment.

5.

Conclusions

In summary, the present meta-analysis was unable to demonstrate a clinically important improvement in mortality as a result of administration of HS. Moreover, we observed administration of HS maybe accompanied with significant increase in blood pressure and serum sodium. Further prospective RCTs with larger sample size and enough statistical power are needed to clarify current issues regarding the use of HS in patient with traumatic hypovolemic shock.

Acknowledgment This work was supported by the grant from Youth Fundation of Beijing Chao-Yang Hospital, Capital Medical University (No.YQ201314). Authors’ contributions: J.-W.W., J.-P.L., Y.-l.S., K.T., Y.W., T.L., P.G., X.L., and Y.W. contributed to analysis and interpretation of data. J.-P.L., Y.-l.S., K.T., Y.W., T.L., P.G., X.L., and Y.W. collected the data. J.-W.W. wrote the article and was in charge of obtaining funding. Q.-H.Z. was responsible for conception and design and critical revision of the article.

Disclosure The authors reported no proprietary or commercial interest in any product mentioned or concept discussed in the article.

Supplementary data Supplementary data related to this article can be found at http://dx.doi.org/10.1016/j.jss.2014.04.027

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Hypertonic saline in the traumatic hypovolemic shock: meta-analysis.

A wealth of evidence from animal experiments has indicated that hypertonic saline (HS) maybe a better choice for fluid resuscitation in traumatic hypo...
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