The overall aim of this study is to determine if there is a bleeding risk associated with the use of starch-containing fluids during cardiac surgery. The specific purpose of this study will be to examine, in a prospective randomized double-blind placebo-controlled fashion, the effects of colloid (HES 130/0.4) vs. crystalloid (Ringer's Lactate) on bleeding in patients undergoing cardiopulmonary bypass for cardiac surgery. The primary end point of this trial will be chest tube output at 24 hours. In addition, a range of secondary end points focusing on transfusion parameters, as well as other important end-organ outcomes, will be determined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
500
33 ml/kg i.v. during surgery
33 ml/kg i.v.
To assess the effect of colloid (HES 130/0.4) administration on blood loss (as determined by chest tube drainage in the first 24 postoperative hours) in patients undergoing cardiac surgery utilizing cardiopulmonary bypass (CPB).
Time frame: first 24 postoperative hours
Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization
Time frame: first 24 postoperative hours
Re-exploration for bleeding
Time frame: first 24 postoperative hours
Total intravenous volume administration required in OR and during first 24 hours post-op hours.
Time frame: first 24 postoperative hours
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