Perioperative volume replacement in children undergoing cardiac surgery: Albumin versus hydroxyethyl starch 130/0.4*

Hanart, C.; Khalifé, Maher; Villé, A. De; Otte, F.; Hert, Stefan De; Linden, Philippe Van der

doi:10.1097/ccm.0b013e3181958c81

Cited by 73 publications

(65 citation statements)

References 26 publications

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“…These latter results were confirmed in a meta-analysis (Martin, Jacob et al, 2013). These two formal analyses are in accordance with the results of two prospective randomized controlled studies performed in children undergoing cardiac surgery, that reported the equivalence of tetrastarches compared to human albumin for perioperative fluid replacement, without any increase in the incidence of postoperative complications (Hanart, Khalife et al, 2009;Van der Linden, De Ville et al, 2013). In these studies, the tetrastarch was associated with a decreased fluid balance, which could have a significant impact on postoperative morbidity and mortality (Hassinger, Wald et al, 2014).…”

Section: Levi Department Of Medicine Academic Medical Centre Unisupporting

confidence: 74%

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2014

Transfusion Medicine

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Section: Levi Department Of Medicine Academic Medical Centre Unisupporting

confidence: 74%

Speaker Abstracts

2014

Transfusion Medicine

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“…13 However, the latter study had some limitations: it was single center, not double blinded; all patients received aprotinin that has been since withdrawn from the market; and most of the observations were limited to the first 24 h after surgery. In addition, a 4% albumin solution was used, which is slightly hypooncotic.…”

Section: Discussionmentioning

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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“…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. Both groups received comparable high volumes of both colloids (50 ml/kg), and measured or calculated blood losses were similar between both groups.…”

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

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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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Perioperative volume replacement in children undergoing cardiac surgery: Albumin versus hydroxyethyl starch 130/0.4*

Abstract: In children undergoing cardiac surgery, 6% HES 130/0.4 may represent an interesting alternative to 4% albumin for intraoperative fluid volume replacement because of its lower cost.

Cited by 73 publications

References 26 publications

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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

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