Hemodynamics, fluids & transfusion

Safety and efficacy of 6% hydroxyethyl starch in patients undergoing major surgery: The randomised controlled PHOENICS trial

Eur J AnaesthesiolPublished Randomised controlled trial

Authors' conclusion

Peri-operative use of HES was noninferior to crystalloids in short-term renal function or a composite of mortality and major complications at 90 days.

Study context

Population
Patients aged 40 to 85 years, ASA II–III, undergoing elective abdominal surgery with expected blood loss at least 500 ml
Participants
1,985 patients
Comparison
6% hydroxyethyl starch (HES) 130/0.4 vs crystalloid solution
  • HESn = 977
  • Crystalloid-onlyn = 981reference
Primary endpoint
Change from pre-operative to lowest cystatin C-based eGFR
Follow-up
First 3 postoperative days
Methodological detailsdouble-blind, non-inferiority, multicentre (53 sites, 10 European countries)
  • Double-blind
  • Non-inferiority
  • Multicentre (53 sites, 10 European countries)

Primary result

As reported in the abstract

Change in eGFR from baseline to minimum

HES

−3.4

mean · SD 17.7 · ml min −1 1.73 m −2

Crystalloid-only

−1.0

mean · SD 17.1 · ml min −1 1.73 m −2

P < 0.001

Secondary outcomes

Composite of mortality and major postoperative complications (key secondary) · 90 days

Any cause mortality · 1 year

Any cause mortality · 1 year

Not significantly different

Safety

Safety endpoints including 90-day renal function

No clinically relevant differences in any safety endpoint

Original publication

Safety and efficacy of 6% hydroxyethyl starch in patients undergoing major surgery: The randomised controlled PHOENICS trial. Eur J Anaesthesiol. Published 24 October 2025. doi:10.1097/eja.0000000000002307

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