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Fluid loading in abdominal surgery - saline versus hydroxyethyl starch (FLASH Trial): study protocol for a randomized
Emmanuel Futier1, Matthieu Biais2, Thomas Godet3
1CHU de Clermont-Ferrand, Département Anesthésie et Réanimation, Pôle Médecine Périopératoire (MPO), Hôpital Estaing, 1 place Lucie Aubrac, 63001, Clermont-Ferrand cedex 1, France. efutier@chu-clermontferrand.fr.
Trials
|December 23, 2015
Summary
The FLASH trial compared hydroxyethyl starch (HES) and saline for surgical fluid therapy. Results will clarify the safety and effectiveness of these common solutions in optimizing hemodynamics and reducing complications.
Area of Science:
- Anesthesiology and Perioperative Medicine
- Critical Care Medicine
- Surgical Patient Management
Background:
- Inappropriate fluid therapy during surgery significantly impacts patient morbidity and mortality.
- Isotonic saline, while common, may pose nephrotoxicity risks.
- Hydroxyethyl starch (HES) use in surgery is debated due to potential acute kidney injury concerns in ICU settings.
Purpose of the Study:
- To compare the efficacy and safety of 6% HES 130/0.4 versus 0.9% saline in surgical patients.
- To evaluate the impact of these fluids on hemodynamic optimization and postoperative outcomes.
- To provide data for informed clinical decisions regarding perioperative fluid management.
Main Methods:
- The FLASH trial is a prospective, multicenter, randomized, double-blinded study.
- 826 high-risk surgical patients were randomized to receive either HES or saline.
- The primary outcome is a composite of death or major postoperative complications within 14 days.
Main Results:
- The study is designed to detect a 10% absolute difference in the primary composite endpoint.
- Statistical power of 95% and a 5% type 1 error rate are established.
- Assuming a 5% mortality and 20% morbidity rate for the composite endpoint.
Conclusions:
- The FLASH trial is expected to yield crucial data on fluid therapy in surgical patients.
- Findings may influence the choice between HES and saline for goal-directed fluid optimization.
- Results could significantly impact perioperative fluid management strategies and patient outcomes.
