Hydroxyethyl Starch and Perioperative Complications: A Systematic Review and Meta-analysis

Area of Science:

• Nephrology
• Anesthesiology
• Critical Care Medicine

Background:

• Regulatory agencies issued warnings on hydroxyethyl starch (HES) due to renal injury concerns in critically ill and septic patients.
• Black box warnings were expanded to surgical and trauma patients, leading to product withdrawals in some regions.
• A previous meta-analysis on perioperative HES use prompted this new study focusing on renal injury in surgical patients.

Purpose of the Study:

• To conduct a new meta-analysis evaluating the renal safety of hydroxyethyl starch (HES) 130/0.4 and HES 130/0.42 in surgical patients.
• To assess the risk of acute kidney injury (AKI) and changes in creatinine concentration following HES administration.
• To complement existing research and address regulatory concerns regarding HES use.

Main Methods:

• Searched 4 publication databases in 6 languages using predefined criteria for relevant trials.
• Included 114 trials (2009-2026) with 13,951 patients, focusing on HES 130/0.4 or HES 130/0.42 use.
• Utilized standard meta-analytic techniques with random-effect models, evaluating trial quality and publication bias.

Main Results:

• HES 130/0.4 or HES 130/0.42 did not significantly increase the risk of acute kidney injury (RR 1.02 [0.91, 1.16]).
• No significant worsening of preoperative-to-postoperative creatinine concentration was observed (-0.62 [-3.82, 2.57] µmol/L).
• Trial sequential analysis confirmed non-inferiority for creatinine change, and HES did not meaningfully worsen other adverse events or mortality.

Conclusions:

• Current hydroxyethyl starch solutions (HES 130/0.4 and HES 130/0.42) do not provoke renal injury in surgical patients.
• The findings support the safe use of these HES formulations within the studied perioperative context.
• Further research may refine understanding, but current evidence suggests renal safety for HES in surgery.