Safety and efficacy of tetrastarches in surgery and trauma: a systematic review and meta-analysis of randomised controlled trials

Chappell, Daniel; Linden, Philippe Van der; Ripollés‐Melchor, Javier; James, Michael F.

doi:10.1016/j.bja.2021.06.040

Cited by 18 publications

(10 citation statements)

References 108 publications

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“…Neither meta-analysis revealed an increase in renal failure or replacement therapy when colloids were administered in surgical patients in need of hypovolemic resuscitation. However, the most recent meta-analysis by Chappell et al demonstrated improved haemodynamic stability, a reduced need for vasopressors and reduced the length of hospital stay by 9 h in surgical patients treated with starches in addition to crystalloids [ 174 ]. The present data in trauma resuscitation do not allow a recommendation as to which of the different colloids is best for the initial management of the bleeding trauma patient.…”

Section: Resultsmentioning

confidence: 99%

The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition

et al. 2023

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Background Severe trauma represents a major global public health burden and the management of post-traumatic bleeding continues to challenge healthcare systems around the world. Post-traumatic bleeding and associated traumatic coagulopathy remain leading causes of potentially preventable multiorgan failure and death if not diagnosed and managed in an appropriate and timely manner. This sixth edition of the European guideline on the management of major bleeding and coagulopathy following traumatic injury aims to advise clinicians who care for the bleeding trauma patient during the initial diagnostic and therapeutic phases of patient management. Methods The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma included representatives from six European professional societies and convened to assess and update the previous version of this guideline using a structured, evidence-based consensus approach. Structured literature searches covered the period since the last edition of the guideline, but considered evidence cited previously. The format of this edition has been adjusted to reflect the trend towards concise guideline documents that cite only the highest-quality studies and most relevant literature rather than attempting to provide a comprehensive literature review to accompany each recommendation. Results This guideline comprises 39 clinical practice recommendations that follow an approximate temporal path for management of the bleeding trauma patient, with recommendations grouped behind key decision points. While approximately one-third of patients who have experienced severe trauma arrive in hospital in a coagulopathic state, a systematic diagnostic and therapeutic approach has been shown to reduce the number of preventable deaths attributable to traumatic injury. Conclusion A multidisciplinary approach and adherence to evidence-based guidelines are pillars of best practice in the management of severely injured trauma patients. Further improvement in outcomes will be achieved by optimising and standardising trauma care in line with the available evidence across Europe and beyond.

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Section: Resultsmentioning

confidence: 99%

The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition

et al. 2023

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“…The safety and effectiveness of HES is likely to differ when used in surgical patients rather than critically ill ones. Recent studies have demonstrated that 6% HES 130/0.4 is not associated with renal dysfunction and increased mortality in patients undergoing surgical procedures [ 52 – 59 ]. In addition, the combination of HES with crystalloids has been shown to have clear advantages, including fewer complications, a higher rate of disability-free survival, and a shorter length of stay compared to crystalloid treatment only [ 52 , 60 , 61 ].…”

Section: Discussionmentioning

confidence: 99%

Respiratory variation in the internal jugular vein does not predict fluid responsiveness in the prone position during adolescent idiopathic scoliosis surgery: a prospective cohort study

Wu,

Dai,

Liang

et al. 2023

BMC Anesthesiol

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Background Respiratory variation in the internal jugular vein (IJVV) has not shown promising results in predicting volume responsiveness in ventilated patients with low tidal volume (Vt) in prone position. We aimed to determine whether the baseline respiratory variation in the IJVV value measured by ultrasound might predict fluid responsiveness in patients with adolescent idiopathic scoliosis (AIS) undergoing posterior spinal fusion (PSF) with low Vt. Methods According to the fluid responsiveness results, the included patients were divided into two groups: those who responded to volume expansion, denoted the responder group, and those who did not respond, denoted the non-responder group. The primary outcome was determination of the value of baseline IJVV in predicting fluid responsiveness (≥15% increases in stroke volume index (SVI) after 7 ml·kg-1 colloid administration) in patients with AIS undergoing PSF during low Vt ventilation. Secondary outcomes were estimation of the diagnostic performance of pulse pressure variation (PPV), stroke volume variation (SVV), and the combination of IJVV and PPV in predicting fluid responsiveness in this surgical setting. The ability of each parameter to predict fluid responsiveness was assessed using a receiver operating characteristic curve. Results Fifty-six patients were included, 36 (64.29%) of whom were deemed fluid responsive. No significant difference in baseline IJVV was found between responders and non-responders (25.89% vs. 23.66%, p = 0.73), and no correlation was detected between baseline IJVV and the increase in SVI after volume expansion (r = 0.14, p = 0.40). A baseline IJVV greater than 32.00%, SVV greater than 14.30%, PPV greater than 11.00%, and a combination of IJVV and PPV greater than 64.00% had utility in identifying fluid responsiveness, with a sensitivity of 33.33%, 77.78%, 55.56%, and 55.56%, respectively, and a specificity of 80.00%, 50.00%, 65.00%, and 65.00%, respectively. The area under the receiver operating characteristic curve for the baseline values of IJVV, SVV, PPV, and the combination of IJVV and PPV was 0.52 (95% CI, 0.38–0.65, p=0.83), 0.54 (95% CI, 0.40–0.67, p=0.67), 0.58 (95% CI, 0.45–0.71, p=0.31), and 0.57 (95% CI, 0.43–0.71, p=0.37), respectively. Conclusions Ultrasonic-derived IJVV lacked accuracy in predicting fluid responsiveness in patients with AIS undergoing PSF during low Vt ventilation. In addition, the baseline values of PPV, SVV, and the combination of IJVV and PPV did not predict fluid responsiveness in this surgical setting. Trail registration This trial was registered at www.chictr.org (ChiCTR2200064947) on 24/10/2022. All data were collected through chart review.

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“…Recent meta-analyses of studies assessing the risk of renal impairment after HES administration, including those performed in trauma patients, have not shown significant differences in postoperative mortality and kidney disfunction [ 26 , 27 ], but a favorable trend towards a reduced hospital length of stay and lower vasopressors requirements for hemodynamic stability during resuscitation in patients treated with HES. The Fluids In Resuscitation of Severe Trauma (FIRST) trial [ 28 ] compared the effect of HES 130/0.4 versus normal saline solution in blunt and penetrating trauma and found comparable efficacy in achieving hemodynamic goals, with better lactate clearance, lower kidney injury rates, and lower alteration in coagulation parameters in patients with penetrating trauma treated with HES 130/0.4, compared to those treated with normal saline.…”

Section: Discussionmentioning

confidence: 99%

PragmaTic, prospEctive, randomized, controlled, double-blind, mulTi-centre, multinational study on the safety and efficacy of a 6% HydroxYethyl Starch (HES) solution versus an electrolyte solution in trauma patients: study protocol for the TETHYS study

Palma¹,

Mamba

Geldenhuys³

et al. 2022

Trials

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Background Trauma may be associated with significant to life-threatening blood loss, which in turn may increase the risk of complications and death, particularly in the absence of adequate treatment. Hydroxyethyl starch (HES) solutions are used for volume therapy to treat hypovolemia due to acute blood loss to maintain or re-establish hemodynamic stability with the ultimate goal to avoid organ hypoperfusion and cardiovascular collapse. The current study compares a 6% HES 130 solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) for volume replacement therapy in adult patients with traumatic injuries, as requested by the European Medicines Agency to gain more insights into the safety and efficacy of HES in the setting of trauma care. Methods TETHYS is a pragmatic, prospective, randomized, controlled, double-blind, multicenter, multinational trial performed in two parallel groups. Eligible consenting adults ≥ 18 years, with an estimated blood loss of ≥ 500 ml, and in whom initial surgery is deemed necessary within 24 h after blunt or penetrating trauma, will be randomized to receive intravenous treatment at an individualized dose with either a 6% HES 130, or an electrolyte solution, for a maximum of 24 h or until reaching the maximum daily dose of 30 ml/kg body weight, whatever occurs first. Sample size is estimated as 175 patients per group, 350 patients total (α = 0.025 one-tailed, power 1–β = 0.8). Composite primary endpoint evaluated in an exploratory manner will be 90-day mortality and 90-day renal failure, defined as AKIN stage ≥ 2, RIFLE injury/failure stage, or use of renal replacement therapy (RRT) during the first 3 months. Secondary efficacy and safety endpoints are fluid administration and balance, changes in vital signs and hemodynamic status, changes in laboratory parameters including renal function, coagulation, and inflammation biomarkers, incidence of adverse events during treatment period, hospital, and intensive care unit (ICU) length of stay, fitness for ICU or hospital discharge, and duration of mechanical ventilation and/or RRT. Discussion This pragmatic study will increase the evidence on safety and efficacy of 6% HES 130 for treatment of hypovolemia secondary to acute blood loss in trauma patients. Trial registration Registered in EudraCT, No.: 2016-002176-27 (21 April 2017) and ClinicalTrials.gov, ID: NCT03338218 (09 November 2017).

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Safety and efficacy of tetrastarches in surgery and trauma: a systematic review and meta-analysis of randomised controlled trials

Cited by 18 publications

References 108 publications

The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition

The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition

Respiratory variation in the internal jugular vein does not predict fluid responsiveness in the prone position during adolescent idiopathic scoliosis surgery: a prospective cohort study

PragmaTic, prospEctive, randomized, controlled, double-blind, mulTi-centre, multinational study on the safety and efficacy of a 6% HydroxYethyl Starch (HES) solution versus an electrolyte solution in trauma patients: study protocol for the TETHYS study

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