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Prophylactic Insulin to Improve Outcomes in Surgical Patients Without Diabetes: A Pilot Randomized, Controlled Trial
*Jamie S. Olapo1, *Robert Schmicker
3, *Bryan Comstock
3, *Erin Fannon
1, *Sara DePaoli
1, *Isaac Knuoff
1, *Irl Hirsch
4, *Evan Dellinger
1, David Flum
1, *Ian Jones
21General Surgery , University of Washington, Seattle, Washington; 2Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington; 3Department of Biostatistics, University of Washington, Seattle, Washington; 4Endocrine and Diabetes Care Center, University of Washington, Seattle, Washington
Introduction: Hyperglycemia during surgery occurs in 1 in 3 patients and significantly increases the risk of morbidity and mortality. While there has been a focus on glycemic control in patients with diabetes (DM), the risk of morbidity and mortality related to hyperglycemia is actually greater for patients without diabetes (NoDM). Treating hyperglycemia with insulin in patients mitigates some of this risk, but we hypothesize that preventing hyperglycemia may be even more effective. Insulin also has anti-inflammatory properties independent of glucose control that may improve surgical outcomes. As prophylactic insulin is not routinely used in NoDM patients, we performed a pilot trial to confirm the safety and feasibility of this approach, administering insulin to surgical patients in combination with glucose and potassium (GIK). Our goal is to eventually conduct a full-scale clinical trial of prophylactic insulin-using GIK- in surgical patients, focused on clinical endpoints.
Methods: A feasibility and safety-focused pilot randomized, placebo-controlled trial of GIK (given pre-operative through the end of surgery) was conducted among NoDM patients undergoing elective, abdominopelvic surgery expected to last >3 hours. Endpoints included the proportion willing to randomize, tolerability of the treatment and safety events. Other outcomes related to efficacy included blood glucose (BG) measures, the use of therapeutic insulin to address hyperglycemia, a blood biomarker of inflammation (neutrophil-lymphocyte ratio [NLR]), and NSQIP-defined adverse events, morbidity and mortality, through postoperative day 30.
Results: 355 patients were approached and 103 (29%) agreed to participate (56% female, median age 58 yrs). Participants randomized to GIK (n=50) or placebo (n=53) underwent general/oncologic (53%), urologic (32%), and gynecologic (15%) procedures. The treatment was completed in full in 97% and there were no serious adverse events. There were no episodes of critical hypoglycemia (BG<54 mg/dL). Euglycemia (<125 mg/dL) was more common in the GIK arm (42%), compared to 28% in control (p<.005). Intraoperative hyperglycemia (BG >140 mg/dL) was less common in the GIK (37%) compared to controls (49%). The use of insulin to treat hyperglycemia was less common in the GIK arm (26% vs 45%, aRR 0.5 [95% CI 0.3, 1.1]). The change in NLR from baseline to POD1 was lower in the GIK group vs placebo. The proportion of patients experiencing a safety event within 30 days in the GIK group (12 vs 21%) was lower (aRR 0.5 [95% CI 0.2, 1.5]) than in the control group.
Conclusion: An RCT of prophylactic insulin in surgical patients is feasible and safe. Though not powered for efficacy, this pilot-RCT found signal that GIK prevents stress hyperglycemia and reduces complications, perhaps mediated by an anti-inflammatory mechanism. A full-scale RCT focused on clinical outcomes is now being developed.
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