Balanced Crystalloid (Sterofundin) vs. Normal Saline for Diabetic Ketoacidosis: A Prospective Intervention Trial with Historical Controls.

Abstract

Fluid therapy with normal saline (NS) in diabetic ketoacidosis (DKA) can cause hyperchloremic acidosis and delay DKA resolution. Balanced crystalloids may address this concern, though results with Ringer lactate and Plasma-Lyte have been mixed. This study aimed to compare the effectiveness of Sterofundin (SF) vs. NS in the management of DKA. A prospective, intervention trial with historical controls was conducted at the Postgraduate Institute of Medical Education and Research, Chandigarh, India. Patients aged 13 years or older with DKA were enrolled. The primary outcome was the time taken to DKA resolution, with a predefined superiority margin of a one-fourth reduction in resolution time. Secondary outcomes included total intravenous fluid and short-acting regular insulin requirements, the need for 0.45% saline, hospital stay duration, and in-hospital mortality. A total of 150 patients (mean age 36.8 years, 56.7% males) were included, with 75 receiving SF (intervention group) and 75 receiving NS (historical control group). The SF group showed a significantly shorter mean time to DKA resolution (13.8 ± 6.0 hours) compared to the NS group (18.1 ± 5.5 hours; P < 0.001). SF patients required less total intravenous fluid (4500 mL vs. 6000 mL; P = 0.004), less insulin (98 units vs. 112 units; P = 0.017), and had a lower need for 0.45% saline (8% vs. 74.3%; P < 0.001). Patients receiving SF had shorter hospital stays (4 [IQR 3-5] days vs. 4 [IQR 4-6] days; P = 0.020). Mortality rates were similar between the groups (SF: 9.3%, NS: 8.1%; P = 0.791). SF may be a superior alternative to NS for fluid therapy in DKA.