Impact of balanced tetrastarch raw material on perioperative blood loss: a randomized double blind controlled trial.

BACKGROUND

As 6% hydroxyethyl starch (HES) 130/0.40 or 130/0.42 can originate from different vegetable sources, they might have different clinical effects. The purpose of this prospective, randomized, double-blind controlled trial was to compare two balanced tetrastarch solutions, one maize-derived and one potato-derived, on perioperative blood loss in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).

METHODS

We randomly assigned 118 patients undergoing elective cardiac surgery into two groups, to receive either a maize- or a potato-derived HES solution. Study fluids were administered perioperatively (including priming of CPB) until the second postoperative day (POD#2) using a goal directed algorithm. The primary outcome was calculated postoperative blood loss up to POD#2. Secondary outcomes included short-term incidence of acute kidney injury (AKI), and long-term effect (up to one yr) on renal function.

RESULTS

Preoperative and intraoperative characteristics of the subjects were similar between groups. Similar volumes of HES were administered (1950 ml [1250-2325] for maize-HES and 2000 ml [1500-2700] for potato-HES; P=0.204). Calculated blood loss (504 ml [413-672] for maize-HES vs 530 ml [468-705] for potato-HES; P=0.107) and the need for blood components were not different between groups. The incidence of AKI was similar in both groups (P=0.111). Plasma creatinine concentration and glomerular filtration rates did vary over time, although changes were minimal.

CONCLUSIONS

Under our study conditions, HES 130/0.4 or 130/0.42 raw material did not have a significant influence on perioperative blood loss. Moreover, we did not find any effect of tetrastarch raw material composition on short and long-term renal function.

CLINICAL TRIAL REGISTRATION

EudraCT number: 2011-005920-16.