Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial.

Area of Science:

• Anesthesiology
• Nephrology
• Cardiovascular Surgery

Background:

• The clinical risks and benefits of starch-based fluid supplementation remain debated, particularly concerning patient-centered outcomes in cardiac surgery.
• Previous research has not adequately explored these outcomes in real-world cardiac surgery settings.

Purpose of the Study:

• To compare the efficacy and safety of a starch-based fluid strategy versus a saline-based fluid strategy in patients undergoing cardiac surgery.
• To evaluate patient-centered outcomes, including acute kidney injury and postoperative weight gain.

Main Methods:

• A pragmatic, blinded, randomized controlled trial was conducted.
• Patients undergoing isolated coronary revascularization received either 6% hydroxyethyl starch or saline for perioperative fluid management.
• Co-primary outcomes included acute kidney injury (AKI) incidence and maximum postoperative weight gain; secondary outcomes assessed bleeding, transfusion needs, and fluid utilization.

Main Results:

• The trial was prematurely terminated due to resource limitations, resulting in a small sample size (n=69).
• No significant difference was observed in the incidence of "risk" stage AKI between the starch and saline groups (Risk Ratio = 1.0; 95% CI = 0.5-1.9).
• While "injury" stage AKI was numerically higher in the starch group (20% vs 9%), this difference was not statistically significant (RR = 2.3; 95% CI = 0.6-8.1). Maximum weight gain, bleeding, transfusion requirements, and overall fluid use were similar between groups.

Conclusions:

• The study was underpowered to detect significant differences in primary outcomes due to early termination.
• The trial demonstrated the feasibility of conducting complex, pragmatic trials in cardiac surgery.
• Hypothesis-generating trends suggest further investigation into fluid strategies in this patient population is warranted.