Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery
Hypothesis: There is no difference in complication rate among patients receiving HES v normal saline during hospitalization for major abdominal surgery.
Methods: Multicenter, double blinded RCT randomizing 818 patients undergoing intermediate to high risk abdominal surgery to receive hydroxyethyl starch vs normal saline. Fluid was administered in 250cc boluses in a protocolized manner predicated on changes in stroke volume index with volume challenge.
Results: There was no difference in primary outcome (14d composite of death, AKI, acute respiratory failure, acute heart failure, major sepsis complications and unplanned reoperation). Secondarily, there was a statistically significant increase in the rate of Stage 1 AKI in the HES group. The HES group also received less total fluid but had a higher rate of blood transfusion.
Strengths:
Protocolized fluid administration
Double blinded
Well powered
Multi center
Appropriate study population
Weaknesses:
HES and NS groups unbalanced (disparate rates of diabetes, etc)
Non-adherence to the study protocol
Questionable generalizability
Key Point: The use of HES vs. normal saline resulted in no significant difference in death or post-operative complication among high risk patients undergoing major abdominal surgery.