Comparison of 6% hydroxyethyl starch 130/0.4 and saline solution for resuscitation of the microcirculation during the early goal-directed therapy of septic patients

Dubin, Arnaldo; Pozo, Mario Omar; Casabella, Christian A.; Murias, Tiberio Feliz; Pálizas, Fernando; Moseinco, Miriam; Edul, Vanina Siham Kanoore; Bakker, Jan; İnce, Can

doi:10.1016/j.jcrc.2010.04.007

Cited by 118 publications

(91 citation statements)

References 30 publications

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“…The 6S [25] and CHEST [3] trials were specifically designed to assess 90-day mortality ( Table 1). The three [41][42][43] older smaller trials reporting mortality at other time points had risk of performance and detection bias, two had risk of selection bias [42,43], one had risk of attrition bias, [41] while another had risk of reporting bias. [42] They were not designed to assess mortality, and the possibility of ascertainment bias could not be dismissed.…”

Section: Study Quality and Biasmentioning

confidence: 99%

“…Four [3,25,26,43] of the six were multicentre, and randomised 3033 patients in critical/intensive care units across Europe, Australasia and South America. Five trials recruited patients with severe sepsis.…”

Section: Description Of Studies and Patientsmentioning

confidence: 99%

“…Five trials recruited patients with severe sepsis. [25,26,[41][42][43] The largest trial [3] recruited sepsis patients in a pre-defined sub-group [49] but those with severe sepsis or septic shock were not reported separately. The median sepsis study sample size was 126 patients (range 24 to 1937).…”

Section: Description Of Studies and Patientsmentioning

confidence: 99%

“…[3,25] A summary measure was not possible because of varied reporting. The proportion of patients with septic shock or those that required vasopressors or inotropes (these were interchangeably reported, often as a composite and variably defined) in four RCTs [25,26,41,43] was 86.0% (range 46 to 100) in 6% tetrastarch groups and 87.5% in control groups, as shown in Table 1 (online supplement). CHEST trial [3] data for their sepsis group were not available.…”

Section: Description Of Studies and Patientsmentioning

confidence: 99%

“…Four studies [3,25,26,41] reported pre-defined 6% tetrastarch dosing details. Five studies [3,25,26,41,43] reported a median total 6% tetrastarch volume infusion of 2615 ml (range 1379 to 3000). The median actual 6% tetrastarch dose exposure was 37.4 ml/kg (range 30 to 43) or 14 ml/kg/day (range 8 to 37).…”

Section: % Tetrastarch Exposurementioning

confidence: 99%

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Randomised trials of 6 % tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis

2013

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PurposeTo assess the impact of 6% tetrastarch (hydroxyethyl starch (HES) 130/0.4 and 130/0.42) in severe sepsis patients. The primary outcome measure was 90-day mortality. MethodsA structured literature search to identify prospective randomized controlled trials (RCT) in adult patients with severe sepsis receiving 6% tetrastarch (potato or waxy maize origin), as part of fluid resuscitation in comparison to other non-HES fluids after randomisation, in the critical care setting was undertaken. A systematic review and meta-analysis was performed. ResultsSix RCTs were included (n = 3033): three from 2012 (n = 2913) had a low risk of bias. Median tetrastarch exposure was 37.4 ml/kg (range 30 to 43). Ninety-day mortality was associated with tetrastarch exposure (relative risk (RR) 1.13; 95% confidence interval (CI) 1.02 to 1.25; p = 0.02) compared to crystalloid. The number needed to harm (NNH) was 28.8 (95% CI 14.6 to 942.5). Publication bias and statistical heterogeneity (I 2 = 0%) were not present. Tetrastarch exposure was also associated with renal replacement therapy (p = 0.01; NNH 15.7) and allogeneic transfusion support (p = 0.001; NNH 9.9). No difference between groups was observed for 28-day mortality, comparison with colloid as control, and for waxy maize derived tetrastarch, but power was lacking. Overall mortality was associated with tetrastarch exposure (RR 1.13; 95% CI 1.02 to 1.25; p = 0.02). ConclusionsIn our analysis, 6% tetrastarch as part of initial fluid resuscitation for severe sepsis was associated with harm, and as alternatives exist, in our view should be avoided.

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