Volume Replacement Therapy during Major Orthopedic Surgery Using Voluven® (Hydroxyethyl Starch 130/0.4) or Hetastarch

Gandhi, Sweeta D.; Weiskopf, Richard B.; Jungheinrich, Cornelius; Koorn, Robert; Miller, Diane; Shangraw, Robert E.; Prough, Donald S.; Baus, Daniela; Bepperling, Frank; Warltier, David C.

doi:10.1097/01.anes.0000265422.07864.37

Cited by 98 publications

(59 citation statements)

References 31 publications

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“…The hemodilution effect of HES 130/0.4 associated with its mode of action was reflected by significant changes in hematological and coagulation parameters. The quick recovery of Factor VIII and vWF in adults after surgery is in line with other findings [3,11,12]. However, it is not possible to separate the effects of profound bleeding from those attributable to hemodilution in an uncontrolled trial.…”

Section: In Patients Undergoingsupporting

confidence: 78%

“…They concluded that the hemodynamic effects of 6% HES 130/0.4 were at least similar to 5% human albumin. Langeron et al (2001) [11] and Gandhi et al (2007) [12] could demonstrate equivalence of 6% HES 130/0.4 with 6% HES 200/0.5 or 6% HES 450/0.7 in volume needed to restore or maintain hemodynamics during orthopedic surgery. Vogt et al (1996) [13] compared 6% HES 200/0.5 with 5% human albumin and demonstrated similar volume needs to stabilize hemodynamics.…”

Section: In Patients Undergoingmentioning

confidence: 97%

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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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Section: In Patients Undergoingsupporting

confidence: 78%

Section: In Patients Undergoingmentioning

confidence: 97%

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

Self Cite

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“…Hydroxyethyl substitution causes the solubility of starch to increase and delays hydrolysis, thus delaying the degradation of starch molecules and excretion. 11 HES is excreted by the kidneys and the rate of decomposition of starch is based on the molar substitution and C2/C6 ratio, which is the substitution of hydroxyethyl at the C2 or C6 location. The higher the molar substitution and C2/C6 ratios, the slower the decomposition, ultimately leading to plasma accumulation.…”

Section: 10mentioning

confidence: 99%

“…However, the problem seems to be associated more with the higher substituted HES that have medium to high MW. 11 An increasing number of prospective studies have compared Voluven with other starches ( Table 2).…”

Section: 10mentioning

confidence: 99%

Voluven, A New Colloid Solution

Mizzi

Tran

Karlnoski

et al. 2011

Anesthesiology Clinics

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A variety of fluid solutions can be used as intravascular replacement for surgical volume loss, and to avoid or delay blood transfusions. Crystalloid solutions, such as Ringer lactate, are typically administered at a rate of 3 or 4 times the volume of blood loss caused by continuous rapid extravasations. Approximately 20% of the volume initially administered remains in the intravascular space hours later. Therefore, rapid infusion of large amounts of crystalloid solutions can cause problems in elderly patients with limited cardiovascular reserve, and can lead to pulmonary and systemic edema. Alternatively, a commonly used synthetic colloid, hydroxyethyl starch (HES), readily allows for a 1:1 replacement ratio of intravascular volume to shed blood, and remains in the intravascular space longer compared with crystalloid solutions. However, HES can induce coagulopathy during prolonged surgical procedures because of the reduced release of factor VIII, von Willebrand Factor (vWF), and impaired platelet function.There are many types of HES according to molecular weight (MW) and degree of substitution (DS). In general, HES with a low MW and low DS is preferred because HES solutions with a high MW and high DS are harder to metabolize and eliminate from the intravascular space. This prolonged stay results in extended adverse effects on coagulation. Six percent HES with a MW of 130 kDa and a DS of 0.4 in a saline medium (Voluven, Fresenius Kabi, Germany) has the lowest MW/DS ratio among other HES on the market and therefore is purported to induce less coagulation impairment. This review of crystalloid and colloid fluid replacement alternatives explores recently published evidence of the clinical utility of Voluven.

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“…2,6 In contrast to the earlier hydroxyethyl starch (HES) solutions, which had a large molecular weight and a high degree of substitution, the new lower molecular weight HES solutions with a lower degree of substitution, such as HES 130/0.4, have shown a favourable pharmacological profile with fewer side effects. [7][8][9][10][11][12][13] Best known for their use as intravascular volume expanders, HES solutions are also associated with microcirculatory improvement and antiinflammatory properties. [14][15][16][17][18] Despite their adverse effects in other settings, namely, on renal function, coagulation, and tissue storage, it was suggested previously that the older high molecular weight HES can reduce the deleterious effect of IRI.…”

Section: Résumémentioning

confidence: 99%

L’hydroxyéthylamidon 130/0,4 atténue les dommages hépatiques précoces causés par les lésions d’ischémie/reperfusion

Catré

Viana

Cabrita

et al. 2010

Can J Anesth/J Can Anesth

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Purpose Ischemia/reperfusion injury (IRI) remains a clinical challenge. We tested the hypothesis that fluid therapy using hydroxyethyl starch (HES) 130/0.4 during the early phase of IRI in rat liver decreases markers of hepatic injury. Methods We induced liver IRI in three groups of rats anesthetized with ketamine and chlorpromazine by means of 60 min of segmental hepatic ischemia followed by 120 min of reperfusion. At the onset of reperfusion, Group 1 (IRI ? HES; n = 12) was given 13 mLÁkg -1 of HES; Group 2 (IRI ? HS; n = 12) received the same volume of 7.5% saline (HS), and Group 3 (IRI-only; n = 12) received no fluid. Three other groups of 12 animals each were shamoperated and received the same fluid as the test groups. We euthanized the animals after three hours, drew blood for alanine aminotransferase (ALT) quantification, and took ischemic liver samples for histomorphological study.Results Serum ALT activity was greater in all of the IRI groups than in the sham-operated animals. The ALT activity was 1,081 ± 575 IUÁL -1 in IRI ? HES Group 1; 2,363 ± 1,839 IUÁL -1 in IRI ? HS Group 2; and 2,866 ± 2,491 IUÁL -1 in IRI-only Group 3. There was a statistically significant difference between the IRI ? HES and the IRIonly groups (P = 0.001), but not between the IRI ? HS and the IRI-only groups (P [ 0.05). Likewise, histological scores were greater in all IRI groups compared with the sham-operated animals. Scores were higher in the IRI-only group (median 3.5) than in the groups receiving fluid (IRI ? HES median 2; IRI ? HS median 3). The difference between IRI ? HES and IRI-only was statistically significant (P = 0.008) but not so between IRI ? HS and IRI-only (P [ 0.05). Conclusions Giving HES 130/0.4 attenuates rat liver IRI compared with no fluid, while giving HS does not. This suggests a role for HES in hepatoprotection associated with liver IRI. RésuméObjectif La le´sion d'ische´mie/reperfusion (IR) reste un de´fi clinique. Nous avons e´mis l'hypothe`se qu'une the´rapie liquidienne a`base d'hydroxye´thylamidon (HES) 130/0,4 administre´e pendant la phase pre´coce d'IR dans un mode`le he´patique de rat, diminuerait les marqueurs de la le´sion he´patique. Méthode Nous avons provoque´une le´sion d'IR au niveau du foie dans trois groupes de rats anesthe´sie´s à la ke´tamine et a`la chlorpromazine en cre´ant une ische´mie he´patique segmentaire de 60 min suivie de 120 min de reperfusion. Au de´but de la reperfusion, le groupe 1 (IR ? HES; n = 12) a reçu 13 mLÁkg -1 de HES; le groupe 2 (IR ? HS; n = 12) a reçu le meˆme volume de se´rum physiologique 7,5 % (HS), et le groupe 3 (IR seule;This investigation was supported, in part, by research funds of the School of Medicine of the University of Coimbra (GAPI 08/08).

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Volume Replacement Therapy during Major Orthopedic Surgery Using Voluven® (Hydroxyethyl Starch 130/0.4) or Hetastarch

Abstract: Voluven (HES 130/0.4) and hetastarch are equally efficacious plasma volume substitutes; however, HES 130/0.4 has a lesser effect on coagulation.

Cited by 98 publications

References 31 publications

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

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

Voluven, A New Colloid Solution

L’hydroxyéthylamidon 130/0,4 atténue les dommages hépatiques précoces causés par les lésions d’ischémie/reperfusion

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