Hydroxyethyl starch versus crystalloid in elective major abdominal surgery: PHOENICS trial

Citation:

Buhre W, Díaz-Cambronero O, Schaefer S, Novacek M, Soro Domingo M, Stessel B, et al. Safety and efficacy of 6% hydroxyethyl starch in patients undergoing major surgery: The randomised controlled PHOENICS trial. Eur J Anaesthesiol. 2025;43:1–10. doi:10.1097/EJA.0000000000002307.

Study at a glance:

- Design and setting: Double-blind, multicentre, parallel-group phase IV noninferiority RCT in adults (40–85 years, ASA II–III) undergoing elective major abdominal surgery with expected blood loss ≥500 ml in 53 European centres (N=1,946 with primary outcome data).

- Interventions: Haemodynamic-guided intra-operative and early postoperative volume replacement with balanced 6% HES 130/0.4 (Volulyte; up to 30 ml kg−1 in 24 h) vs balanced crystalloid-only (Ionolyte) within the same goal-directed algorithm.

- Primary outcome (change in cystatin C–eGFR to lowest value within 3 postop days): LS mean difference HES vs crystalloid −2.6 ml min−1 1.73 m−2 (95% CI −4.1 to −1.1), well within the prespecified noninferiority margin (−8.1 ml min−1 1.73 m−2) — no clinically important short-term renal impairment; moderate-certainty evidence.

- Key secondary: 90-day composite of all-cause mortality and major postoperative complications in 35% of patients in both groups (adjusted risk difference 0.6%, 95% CI −3.8 to 5.1) — no clear difference; 90-day and 1-year mortality and need for renal replacement therapy were also similar but imprecisely estimated (low-certainty for hard outcomes).

- Perioperative haemodynamics and safety: HES yielded slightly lower net positive fluid balance (0.6 vs 1.2 l), smaller MAP decrease (−14 vs −16 mmHg), and fewer patients needing vasoactive/inotropic drugs (26% vs 35%); overall adverse events, serious events, AKI (RIFLE/AKIN), and adverse drug reactions were comparable, with findings applicable to stable elective abdominal surgery patients without sepsis or pre-existing renal dysfunction (not to ICU/sepsis resuscitation).