Limits...
Efficacy and safety of 6% hydroxyethyl starch 130/0.4 (Voluven) for perioperative volume replacement in children undergoing cardiac surgery: a propensity-matched analysis.

Van der Linden P, Dumoulin M, Van Lerberghe C, Torres CS, Willems A, Faraoni D - Crit Care (2015)

Bottom Line: Secondary safety outcomes were mortality and the incidence of postoperative renal dysfunction.In addition, its use might be associated with less fluid accumulation.Further large studies are needed to assess whether the reduction in fluid accumulation could have a significant impact on postoperative morbidity and mortality.

View Article: PubMed Central - PubMed

Affiliation: Department of Anesthesiology, University Hospital Brugmann and Queen Fabiola Children's University Hospital, Free University of Brussels, 4 Place Van Gehuchten, B-1020, Brussels, Belgium. philippe.vanderlinden@chu-brugmann.be.

ABSTRACT

Introduction: Six percent hydroxyethyl starch (HES) 130/0.4 is considered an alternative to human albumin (HA) and crystalloids for volume replacement in children undergoing cardiac surgery. In this large propensity-matched analysis, we aimed to assess the efficacy and safety of replacing HA with HES for intraoperative volume therapy in children undergoing cardiac surgery with cardiopulmonary bypass (CPB).

Methods: We retrospectively reviewed our database, including children who underwent cardiac surgery between January 2002 and December 2010. Four percent HA was used until 2005; it was replaced by HES thereafter. Demographic data, intra- and postoperative blood loss and blood component transfusions were recorded, together with the incidence of postoperative complications and mortality. We performed a propensity-matched analysis using 13 possible confounding factors to compare children who received either HES or HA intraoperatively. The primary objectives included the effects of both fluids on intraoperative fluid balance (difference between fluids in and fluids out (efficacy)) and blood loss and exposure to allogeneic blood products (safety). Secondary safety outcomes were mortality and the incidence of postoperative renal dysfunction.

Results: Of 1,832 children reviewed, 1,495 were included in the analysis. Intraoperative use of HES was associated with a less positive fluid balance. Perioperative blood loss, volume of red blood cells and fresh frozen plasma administered, as well as the number of children who received transfusions, were also significantly lower in the HES group. No difference was observed regarding the incidence of postoperative renal failure requiring renal replacement therapy or of morbidity and mortality.

Conclusions: These results confirm that the use of HES for volume replacement in children during cardiac surgery with CPB is as safe as HA. In addition, its use might be associated with less fluid accumulation. Further large studies are needed to assess whether the reduction in fluid accumulation could have a significant impact on postoperative morbidity and mortality.

Show MeSH

Related in: MedlinePlus

Flowchart of the study. ASA, American Society of Anesthesiologists physical status; CPB, Cardiopulmonary bypass; FFP, Fresh frozen plasma; HA, Human albumin; HES, Hydroxyethyl starch; RCT, Randomized controlled trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC4376346&req=5

Fig1: Flowchart of the study. ASA, American Society of Anesthesiologists physical status; CPB, Cardiopulmonary bypass; FFP, Fresh frozen plasma; HA, Human albumin; HES, Hydroxyethyl starch; RCT, Randomized controlled trial.

Mentions: Of the 1,832 children included in our departmental database, 1,495 were included in the final analysis (Figure 1). We excluded 83 children because relevant data were missing, 82 because FFP was used primarily in the CPB prime, 7 who were in a moribund state and 5 Jehovah’s witnesses. In addition, 160 children were voluntarily excluded because they had already participated in 1 of the 2 prospective trials performed in our department, in which we compared 6% HES 130/0.4 with HA [14,15].Figure 1


Efficacy and safety of 6% hydroxyethyl starch 130/0.4 (Voluven) for perioperative volume replacement in children undergoing cardiac surgery: a propensity-matched analysis.

Van der Linden P, Dumoulin M, Van Lerberghe C, Torres CS, Willems A, Faraoni D - Crit Care (2015)

Flowchart of the study. ASA, American Society of Anesthesiologists physical status; CPB, Cardiopulmonary bypass; FFP, Fresh frozen plasma; HA, Human albumin; HES, Hydroxyethyl starch; RCT, Randomized controlled trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4376346&req=5

Fig1: Flowchart of the study. ASA, American Society of Anesthesiologists physical status; CPB, Cardiopulmonary bypass; FFP, Fresh frozen plasma; HA, Human albumin; HES, Hydroxyethyl starch; RCT, Randomized controlled trial.
Mentions: Of the 1,832 children included in our departmental database, 1,495 were included in the final analysis (Figure 1). We excluded 83 children because relevant data were missing, 82 because FFP was used primarily in the CPB prime, 7 who were in a moribund state and 5 Jehovah’s witnesses. In addition, 160 children were voluntarily excluded because they had already participated in 1 of the 2 prospective trials performed in our department, in which we compared 6% HES 130/0.4 with HA [14,15].Figure 1

Bottom Line: Secondary safety outcomes were mortality and the incidence of postoperative renal dysfunction.In addition, its use might be associated with less fluid accumulation.Further large studies are needed to assess whether the reduction in fluid accumulation could have a significant impact on postoperative morbidity and mortality.

View Article: PubMed Central - PubMed

Affiliation: Department of Anesthesiology, University Hospital Brugmann and Queen Fabiola Children's University Hospital, Free University of Brussels, 4 Place Van Gehuchten, B-1020, Brussels, Belgium. philippe.vanderlinden@chu-brugmann.be.

ABSTRACT

Introduction: Six percent hydroxyethyl starch (HES) 130/0.4 is considered an alternative to human albumin (HA) and crystalloids for volume replacement in children undergoing cardiac surgery. In this large propensity-matched analysis, we aimed to assess the efficacy and safety of replacing HA with HES for intraoperative volume therapy in children undergoing cardiac surgery with cardiopulmonary bypass (CPB).

Methods: We retrospectively reviewed our database, including children who underwent cardiac surgery between January 2002 and December 2010. Four percent HA was used until 2005; it was replaced by HES thereafter. Demographic data, intra- and postoperative blood loss and blood component transfusions were recorded, together with the incidence of postoperative complications and mortality. We performed a propensity-matched analysis using 13 possible confounding factors to compare children who received either HES or HA intraoperatively. The primary objectives included the effects of both fluids on intraoperative fluid balance (difference between fluids in and fluids out (efficacy)) and blood loss and exposure to allogeneic blood products (safety). Secondary safety outcomes were mortality and the incidence of postoperative renal dysfunction.

Results: Of 1,832 children reviewed, 1,495 were included in the analysis. Intraoperative use of HES was associated with a less positive fluid balance. Perioperative blood loss, volume of red blood cells and fresh frozen plasma administered, as well as the number of children who received transfusions, were also significantly lower in the HES group. No difference was observed regarding the incidence of postoperative renal failure requiring renal replacement therapy or of morbidity and mortality.

Conclusions: These results confirm that the use of HES for volume replacement in children during cardiac surgery with CPB is as safe as HA. In addition, its use might be associated with less fluid accumulation. Further large studies are needed to assess whether the reduction in fluid accumulation could have a significant impact on postoperative morbidity and mortality.

Show MeSH
Related in: MedlinePlus