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Hydroxyethyl Starch on Kidney and Haemostatic Function in Cardiac Surgical Patients: Is A Non-Inferiority Study Design Appropriate for This Setting?
In light of the existing concerns on HES use, this study leaves several unanswered questions: how should patients be informed when they are asked to participate in a clinical trial that may randomise them to receive HES? How can a prestigious research group consider it appropriate to adopt a ’non‐inferiority’ study design to evaluate the safety profile of a controversial drug such as HES, when any proven beneficial effects (if there are any) remain unanswered?
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Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery The FLASH Randomized Clinical Trial
Among patients at risk of postoperative kidney injury undergoing major abdominal surgery, use of HES for volume replacement therapy compared with 0.9% saline resulted in no significant difference in a composite outcome of death or major postoperative complications within 14 days after surgery.
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Hydroxyethyl Starch and Acute Kidney Injury in High-Risk Patients Undergoing Cardiac Surgery: A Prospective Multicenter Study
The use of modern hydroxyethyl starch 6% HES 130/0.4 was not associated with an increased risk of AKI nor dialysis in this cohort of patients at elevated risk for developing AKI after cardiac surgery.
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