HES 130/0.4 (Voluven®) or human albumin in children younger than 2 yr undergoing non-cardiac surgery. A prospective, randomized, open label, multicentre trial

Standl, Thomas; Lochbuehler, H.; Galli, C.; Reich, Alexander; Dietrich, G.; Hagemann, H

doi:10.1017/s0265021508003888

Cited by 51 publications

(25 citation statements)

References 31 publications

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“…In addition, most of these data are obtained from low-risk population, and/or the volume of tetrastarch used was relatively low. 9,10 Further evaluation of the efficacy and safety of tetrastarches in a surgical pediatric population will require a surgical procedure associated with the use of high volumes of a colloid and a relatively high risk of complications like bleeding and renal dysfunction.…”

Section: Perioperative Medicinementioning

confidence: 99%

Six Percent Hydroxyethyl Starch 130/0.4 (Voluven®) versus 5% Human Serum Albumin for Volume Replacement Therapy during Elective Open-heart Surgery in Pediatric Patients

et al. 2013

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Background: Although 5% albumin (human serum albumin [HSA]) is widely used in cardiac surgery children, synthetic colloids may provide a valuable alternative. This study compared 6% hydroxyethyl starch (HES) 130/0.4 with HSA for volume replacement in this population. Methods: The study was a two-center, randomized, controlled, parallel-group, double-blind trial performed in children aged 2-12 yr undergoing elective surgery for congenital heart disease under extracorporeal circulation. The primary objective was to demonstrate equivalence between HES and HSA with regard to the total volume of colloid infusion for intraoperative volume replacement including priming of the extracorporeal circuitery. Results: In the per-protocol population, mean volume of colloid required until end of surgery was (mean ± SD) 36.6 ± 11.8 ml/kg body weight in the HES group (N = 29) and 37.0 ± 11.9 ml/kg body weight in the HSA group (N = 26; ratio of means HES/HSA = 0.98 [95% CI, 0.84-1.16]). Intraoperative fluid balance was less positive in the HES group (P = 0.047). No difference was found regarding hemodynamics, the use of vasoactive and inotropic drugs. Blood loss, erythrocytes transfusion, and renal function were not different between groups. The incidence of adverse events up to postoperative day 28 did not differ between the groups. Conclusions: In pediatric cardiac surgery, HES showed equivalence to HSA with regard to volume replacement therapy in children aged from 2 to 12 yr. Although there was no suggestion of an imbalance of safety measures between HES and HSA, the study was not powered to provide any firm conclusions about safety of tetrastarch in this population.

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Section: Perioperative Medicinementioning

confidence: 99%

Six Percent Hydroxyethyl Starch 130/0.4 (Voluven®) versus 5% Human Serum Albumin for Volume Replacement Therapy during Elective Open-heart Surgery in Pediatric Patients

et al. 2013

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“…Comparable efficacy of both colloids has been previously demonstrated in several studies among different age groups of patients and clinical settings. In a study by Standl et al (2008) [7] comparable volumes of 6% HES 130/0.4 and 5% human albumin were infused in 82 small infants (<2 years) undergoing non-cardiac surgery to restore or maintain hemodynamic stabilization. Hanart et al (2009) [8] compared the effects of 6% HES 130/0.4 and 4% human albumin on perioperative blood loss and intraoperative volume requirements in 119 pediatric patients undergoing cardiac surgery.…”

Section: Discussionmentioning

confidence: 99%

The Volume Effect and Safety of 6% Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery: An Uncontrolled, Open-Labeled, Multi-Center Study

Morioka¹,

Ozaki²,

Yamakage³

et al. 2013

OJAnes

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Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need to infuse human albumin may be reduced or avoided in Japan if these large doses 6% HES 130/0.4 can be infused. Methods: The study was an uncontrolled, open-labeled, multi-center trial. Fifteen adult and 5 pediatric patients undergoing major elective surgery received 6% HES 130/0.4 (Voluven ® ) with a maximum dose of 50 mL/kg from the start of surgery until 2 hours after the end of surgery according to a treatment algorithm. The primary efficacy endpoint was the volume effect of 6% HES 130/0.4 determined by the volume of saved albumin during the investigational period and the time course of hemodynamic stability in adult and pediatric patients. Safety parameters were fluid balance, hemodynamic and laboratory parameters ECG, local and systemic tolerance and adverse events. Results: Adult patients received a mean of 32.0 mL/kg of 6% HES 130/0.4. For 12 out of 15 adult patients an average amount of 1033.8 mL (18.6 mL/kg) albumin could be saved. The other 3 adult patients did not receive more than 1000 mL of HES 130/0.4. All pediatric patients received approximately 50 mL/kg of HES 130/0.4; for these patients an average amount of 39.9 mL/kg body weight albumin could be saved. The majority of adult patients, and all pediatric patients were hemodynamically stable at all 3 time points. The observed changes of the assessed laboratory parameters including hematological and coagulation parameters or in any other safety parameter determined did not reveal any safety concern related to the administration of 6% HES 130/0.4 up to doses of 50 mL/kg body weight. Conclusion: The study results indicate that 6% HES 130/0.4 has a reliable volume effect, could contribute to significant human albumin savings and was safe and well tolerated up to a maximum dose of 50 mL/kg body weight in adult and pediatric patients undergoing major elective surgery.

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“…While the number of studies is limited, the effects of human albumin versus those of synthetic colloid solutions are comparable when used for perioperative volume replacement in neonates and older children [41,102]. …”

Section: Human Albuminmentioning

confidence: 99%

Cross-Sectional Guidelines for Therapy with Blood Components and Plasma Derivatives: Chapter 5 Human Albumin - Revised

2016

Transfus Med Hemother

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HES 130/0.4 (Voluven®) or human albumin in children younger than 2 yr undergoing non-cardiac surgery. A prospective, randomized, open label, multicentre trial

Abstract: Both HES 130/0.4 and human albumin 5% were effective for haemodynamic stabilization in non-cardiac surgery of young infants with no adverse impact on coagulation or other safety parameters in our study population.

Cited by 51 publications

References 31 publications

Six Percent Hydroxyethyl Starch 130/0.4 (Voluven®) versus 5% Human Serum Albumin for Volume Replacement Therapy during Elective Open-heart Surgery in Pediatric Patients

Six Percent Hydroxyethyl Starch 130/0.4 (Voluven®) versus 5% Human Serum Albumin for Volume Replacement Therapy during Elective Open-heart Surgery in Pediatric Patients

The Volume Effect and Safety of 6% Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery: An Uncontrolled, Open-Labeled, Multi-Center Study

Cross-Sectional Guidelines for Therapy with Blood Components and Plasma Derivatives: Chapter 5 Human Albumin - Revised

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