Related Experiment Video
Updated: Dec 12, 2025
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial
A Dave Nagpal1,2, Andrea Cowan3, Linna Li1
1Department of Surgery, Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON, Canada.
Background:
Despite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a "real-world" trial in cardiac surgery.
Objective:
We sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient.
Design:
A pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strategy.
Setting:
A large tertiary academic center in London Ontario between September 2009 and February 2011.
Participants:
Patients undergoing planned, isolated coronary revascularization.
Measurements:
Serum creatinine and patient weight were measured daily postoperatively.
Methods:
Patients were randomized to receive 6% hydroxyethyl starch (Voluven) or saline for perioperative fluid requirements. Fluid administration was not protocolized. Co-primary outcomes were incidence of acute kidney injury (AKI) and maximum postoperative weight gain. Secondary outcomes included bleeding, transfusion, inotropic and ventilator support, and fluid utilization.
Results:
The study was prematurely terminated due to resource limitations. A total of 69 patients (19% female, mean age = 65) were randomized. Using RIFLE criteria for AKI, "risk" occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95% confidence interval [CI] = 0.5-1.9; P = 1.00), whereas "injury" occurred in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline groups, respectively (RR = 2.3; 95% CI = 0.6-8.1; P = .31). Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups.
Limitations:
The study had to be prematurely terminated due to resource limitations which led to a small sample size which was not sufficiently powered to detect a difference in the primary outcomes.
Conclusions:
This pragmatic double-blinded randomized controlled trial revealed a number of interesting hypothesis-generating trends and confirmed the feasibility of undertaking a logistically complex trial in a pragmatic fashion.
